Drug delivery implants

ABSTRACT

An orthopedic implant includes an internal fixation device. The internal fixation device includes: an exterior surface; a threaded section including a reservoir and at least one threaded section channel fluidly communicating the reservoir with the exterior surface, each threaded section channel having an interior diameter and a length which is greater than the interior diameter; a head including a head channel fluidly communicating the reservoir with an exterior surface of the head, a channel diameter of the head channel being respectively larger than a largest interior diameter of each threaded section channel, the channel diameter of the head channel being the same as a large interior diameter of the reservoir; and a continuously tapering inner surface between the head channel and the reservoir.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 15/413,493,entitled “DRUG DELIVERY IMPLANTS”, filed Jan. 24, 2017, which isincorporated herein by reference. U.S. patent application Ser. No.15/413,493 is a divisional of U.S. patent application Ser. No.12/549,748, now U.S. Pat. No. 9,616,205, entitled “DRUG DELIVERYIMPLANTS,” filed Aug. 28, 2009, which is incorporated herein byreference. U.S. patent application Ser. No. 12/549,748 is anon-provisional application based upon U.S. provisional patentapplication Ser. No. 61/092,880, entitled “DRUG DELIVERY IMPLANT”, filedAug. 29, 2008, and is also a continuation-in-part of U.S. patentapplication Ser. No. 12/540,676, entitled “DRUG DELIVERY IMPLANTS”,filed Aug. 13, 2009, which are both incorporated herein by reference.U.S. patent application Ser. No. 12/540,676 is a non-provisionalapplication based upon U.S. provisional patent application Ser. No.61/088,379, entitled “DRUG DELIVERY IMPLANTS”, filed Aug. 13, 2008,which is incorporated herein by reference. Further, U.S. patentapplication Ser. No. 12/549,748 is a continuation-in-part of U.S. patentapplication Ser. No. 12/540,760, now U.S. Pat. No. 8,475,505, entitled“ORTHOPAEDIC SCREWS”, filed Aug. 13, 2009, which is incorporated hereinby reference. U.S. patent application Ser. No. 12/540,760 is anon-provisional application based upon U.S. provisional patentapplication Ser. No. 61/088,383, entitled “ORTHOPAEDIC SCREWS”, filedAug. 13, 2008, which is incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to implants, and, more particularly, toorthopaedic implants.

2. Description of the Related Art

Orthopaedic implants include short-term implants, long-term implants,and non-permanent implants. Short-term implants include implants for thetreatment of infection. Long-term implants include total implants fortotal hip, knee, shoulder, and elbow joints. Non-permanent implantsinclude trauma products such as nails, plates, and external fixationdevices.

Regarding short-term implants, when tissue, especially bone, surroundingan orthopaedic implant becomes infected, that implant must typically beremoved, the infection must be eliminated, and a new implant (revisionimplant) is then implanted. The span of time between implant removal andrevision implantation can be from several weeks (about 4 weeks) to a fewmonths (approximately 3 months). During this time surgeons currentlyhave two basic options: create temporary implants during surgery withantibiotic bone cement (created with or without the aid of a mold) oruse a preformed antibiotic bone cement temporary implant (e.g.Exactech's InterSpace™ Hip and Knee). In either case, antibiotic bonecement is used to deliver antibiotics directly to the site of theinfection in the bone. The patient also typically receives IVantibiotics. The shortcomings of such implants are the limited durationin which they deliver a clinically relevant dose of antibiotics, thelack of ability to change antibiotic type or dose during the 4-12 weektreatment time, and the limited patient mobility, range of motion, andweight bearing that they allow.

Further, antibiotic cements typically provide useful local antibioticlevels for a duration of less than one week. The treatment time isfrequently 6 to 8 weeks. However, beyond one week, the antibiotic cementimplants provide no useful amount of antibiotics.

Further, infections can be caused by a great number of bacteria,viruses, yeast, etc. The effectiveness of various antibiotics dependsgreatly upon what in particular has caused the infection. Thus, in orderto treat an infection most effectively, the cause of that infection mustbe known. The results of cell cultures give this information andindicate which antibiotic and dose will most effectively treat theinfection. The samples for culturing are usually collected duringsurgery. The results of the culture are not known until several daysafter the surgery. Since the type of antibiotic cement used in currenttemporary implants must be chosen at or before the time of surgery, theinformation gained from the cultures cannot be applied to theantibiotics used at the infection site.

Further, one key to a patient recovering from joint surgery with fullrange of motion in that joint is to encourage movement of that joint.This helps to prevent the formation of scar tissue and stiffening oftissue around the joint. The current options for temporary implantsallow limited range of motion and weight bearing at best.

Regarding long-term implants, with regard to bone ingrowth, boneingrowth into a porous material is sometimes required to providestability or fixation of an implant to the bone. Examples of thisinclude porous coatings on total joint components, fusion devices (i.e.,spinal fusion devices), and bone augmentation components (i.e., tibialwedges).

With regard to resorbtion, resorbtion can occur in the regionsurrounding a total joint implant for a number of reasons and can leadto implant loosening and subsequent revision surgery. Some causes ofresorbtion include: (1) Stress shielding—Bone tissue requires loading toremain strong and healthy. If an implant does not properly transferloads to the surrounding bone, regions of bone can resorb; (2) Lysis dueto wear particles—Osteolysis and resorbtion are frequently caused by thebody's reaction to wear particles created by the bearing of one totaljoint component on another; (3) Osteoporosis or other bonedisorders—bone metabolic disorders can also cause the resorbtion ofbone.

With regard to oncology, localized delivery of oncological drugs in theregion of tumors may improve results in slowing/halting tumor growth.The ability for localized delivery may also lessen the need/dose ofsystemic drugs, resulting in fewer side effects.

Regarding non-permanent implants (i.e., trauma implants), suchnon-permanent implants include nails, plates, and external fixationdevices. Nails are temporary, intramedullary devices. They are typicallyused to treat traumatic fracture. The risk of infection can be highespecially in the case of open fractures. With regard to oncology, nailscan be used to treat fractures associated with bone tumors. They canalso be used to help prevent a fracture where cancer has weakened bone.Plates treat many of the same indications as nails; however plates areapplied to the outside of the bone. External fixation devices are atemporary implant that is used to stabilize a fracture. These can beused for days to months. External fixation devices typically includeseveral pins fixed in the bone and extending through the skin to a rigidplate, ring, rod, or similar stabilizing device. These devices carry theadded risk of infection due to their extending through the skin.Bacteria can travel along the pins directly to the soft tissue and bone.

Further, orthopaedic implants include internal fixation devices andporous devices. Internal fixation devices include, but are not limitedto, screws and anchors.

What is needed in the art is an orthopaedic implant which includes areservoir and a plurality of channels leading from the reservoir todeliver at least one therapeutic agent locally to bone or surroundingsoft tissue, the orthopaedic implant being an internal fixation deviceand/or a porous device.

SUMMARY OF THE INVENTION

The present invention provides an orthopaedic implant which includes areservoir and a plurality of channels leading from the reservoir todeliver at least one therapeutic agent locally to bone or surroundingsoft tissue, the orthopaedic implant being an internal fixation deviceand/or a porous device.

The invention in one form is directed to an orthopaedic implant system,including an orthopaedic implant implantable at a selected locationwithin a corporeal body and configured for delivering at least onetherapeutic agent to the corporeal body, the implant defining areservoir and a plurality of channels, the reservoir configured forreceiving the at least one therapeutic agent, the plurality of channelsconfigured for conveying the at least one therapeutic agent from thereservoir to a treatment site relative to the corporeal body, theimplant being at least one of an internal fixation device and a porousdevice.

The invention in another form is directed to a method of using anorthopaedic implant system, the method including the steps of: providingan orthopaedic implant defining a reservoir and a plurality of channels,the implant being at least one of an internal fixation device and aporous device; implanting the implant at a selected location within thecorporeal body; receiving at least one therapeutic agent in thereservoir; conveying the at least one therapeutic agent from thereservoir to a treatment site relative to the corporeal body via theplurality of channels; and delivering the at least one therapeutic agentto the corporeal body.

The invention in another form is directed to a method of using anorthopaedic implant, the method including the steps of: providing anorthopaedic implant body defining at least one pathway; receiving atleast one therapeutic agent by the implant body; implanting theorthopaedic implant at a selected location within a corporeal body;conveying the at least one therapeutic agent from the implant body to atreatment site relative to the corporeal body via the at least onepathway using pressure generated by the corporeal body to mechanicallyforce the at least one therapeutic agent from the implant body to thetreatment site.

The invention in another form is directed to a method of using anorthopaedic implant, the method including the steps of: providing anorthopaedic implant defining a reservoir and a plurality of channels;implanting the implant at a selected location within a corporeal body,the implant being implanted into soft tissue of the corporeal body;receiving at least one therapeutic agent in the reservoir; conveying theat least one therapeutic agent from the reservoir to a treatment siterelative to the corporeal body via said plurality of channels; anddelivering the at least one therapeutic agent to the corporeal body.

An advantage of the present invention is that it provides an orthopaedicimplant that allows for the delivery of drugs directly to the boneand/or surrounding soft tissue.

Another advantage of the present invention is that it provides atemporary or short-term implant that would allow for the delivery ofantibiotics directly to the bone and surrounding tissue.

Yet another advantage of the present invention is that it would allowfor post-operative injections of antibiotics into the implant, therebyallowing for the delivery of multiple antibiotics throughout treatment.

Yet another advantage of the present invention is that the implantaccording to the present invention allows for the delivery of thecorrect dose of antibiotics, continuously for any length of timerequired.

Yet another advantage of the present invention is that is provides anorthopaedic implant which can deliver a therapeutic agent locally tobone or surrounding soft tissue as long as the implant remains implantedin a corporeal body.

Yet another advantage of the present invention is that it provides along-term implant which would allow drugs to be delivered directly tothe bone and surrounding tissue (or to any specific location).

Yet another advantage of the present invention is that, with regard toenhancing bone ingrowth and combating resorbtion, it provides that bonegrowth stimulators can be injected intraoperatively or postoperativelyto enhance or speed bone ingrowth into porous material (i.e., porouscoatings on total joint components; fusion devices, i.e., spinal fusiondevices; bone augmentation components, i.e., tibial wedges); these drugscould also be injected months to years post-operatively, using animplant according to the present invention, to combat bone resorbtiondue to such causes as stress-shielding, osteolysis, or bone metabolicdisorders.

Yet another advantage of the present invention is that, with regard tooncology, the present invention provides an implant that would similarlyallow for delivery of drugs to some or all tissue surrounding theimplant.

Yet another advantage of the present invention is that it would allowantibiotics to be delivered to the bone surrounding the nail of thepresent invention as a preventative or to treat an infection if onedevelops.

Yet another advantage of the present invention is that it provides anon-permanent implant, such as a nail according to the presentinvention, which can provide the delivery of bone growth stimulatorsdirectly to the region of bone fracture(s); such delivery of bone growthstimulators can be advantageous in difficult cases such as non-unions,bony defects, and osteotomies.

Yet another advantage of the present invention is that it provides anon-permanent implant, such as a nail according to the presentinvention, which can provide localized delivery of oncological drugs inthe region of tumors which may improve results in slowing/halting tumorgrowth; this ability for localized delivery provided by the presentinvention may also lessen the need/dose of systemic drugs, resulting infewer side effects.

Yet another advantage of the present invention is that it provides anexternal fixation device that would allow antibiotics or otheranti-infective agents to be provided to the bone and soft tissuesurrounding the pins.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of this invention,and the manner of attaining them, will become more apparent and theinvention will be better understood by reference to the followingdescription of embodiments of the invention taken in conjunction withthe accompanying drawings, wherein:

FIG. 1 is a schematic representation of a sectional view of a short-termfemoral hip implant according to the present invention;

FIG. 2 is a schematic representation of a sectional view of a short-termfemoral hip implant system according to the present invention;

FIG. 3 is a schematic representation of a sectional view of a short-termacetabular cup implant according to the present invention;

FIG. 4 is a schematic representation of a top view of a short-termfemoral knee implant according to the present invention;

FIG. 5 is a schematic representation of a sectional view of theshort-term femoral knee implant taken along line 5-5 in FIG. 4;

FIG. 6 is a schematic representation of a top view of a short-termfemoral knee implant according to the present invention;

FIG. 7 is a schematic representation of a front view of short-termfemoral knee implant;

FIG. 8 is a schematic representation of a sectional view of a short-termtibial knee implant;

FIG. 9 is a schematic representation of a side view of a long-termfemoral hip implant system according to the present invention;

FIG. 10 is a schematic representation of a sectional view of thelong-term femoral hip implant of FIG. 9;

FIG. 11 is a schematic representation of a top view of a long-termfemoral knee implant according to the present invention;

FIG. 12 is a schematic representation of a sectional view of thelong-term femoral knee implant taken along line 12-12 in FIG. 11;

FIG. 13 is a schematic representation of a top view of a long-termfemoral knee implant system according to the present invention;

FIG. 14 is a schematic representation of a side view of a long-termfemoral knee implant system according to the present invention, thelong-term femoral implant being attached to a femur;

FIG. 15 is a schematic representation of a side view of a long-termfemoral hip implant system according to the present invention;

FIG. 16 is a schematic representation of a sectional view of thelong-term femoral hip implant system of FIG. 15 taken along line 16-16;

FIG. 17 is a schematic representation of a sectional view of anorthopaedic nail according to the present invention;

FIG. 18 is a schematic representation of a sectional view of anorthopaedic plate according to the present invention;

FIG. 19 is a schematic representation of a sectional view of an externalfixation device according to the present invention;

FIG. 20 is a schematic representation of a sectional view of anorthopaedic implant system including a therapeutic agent cartridge;

FIG. 21 is a schematic representation of a sectional view of anorthopaedic implant of FIG. 20 without the therapeutic agent cartridgeinserted therein;

FIG. 22 is a schematic representation of a side view of an orthopaedicimplant that is entirely porous;

FIG. 23 is a schematic representation of a side view of an orthopaedicimplant that is entirely porous and includes a reservoir and drugdelivery channels according to the present invention;

FIG. 24 is a schematic representation of a sectional view of anorthopaedic implant that is partially porous;

FIG. 25 is a schematic representation of a sectional view of anorthopaedic implant that is partially porous and includes a reservoirand drug delivery channels according to the present invention;

FIG. 26 is a schematic representation of a sectional view of anorthopaedic implant that is partially porous and includes a reservoirand drug delivery channels according to the present invention;

FIG. 27 is a schematic representation of a sectional view of anorthopaedic implant system according to the present invention includinga sponge-like material;

FIG. 28 is a schematic representation of an orthopaedic implant systemaccording to the present invention;

FIG. 29 is a schematic representation of an orthopaedic implant systemaccording to the present invention.

FIG. 30 is a schematic representation of a sectional view of an internalfixation device, in the form of a bone screw, according to the presentinvention;

FIG. 31 is a schematic representation of a side view of the bone screwof FIG. 30 inserted into a femur;

FIG. 32 is a schematic representation of a sectional view of anorthopaedic implant system according to the present invention includinga bone screw and a reservoir attached thereto;

FIG. 33 is a schematic representation of a sectional view of anorthopaedic implant system according to the present invention includinga bone screw and a reservoir attached thereto;

FIG. 34 is a schematic representation of a sectional view of anorthopaedic implant system according to the present invention includinga bone screw, a catheter, and a remote reservoir;

FIG. 35 is a schematic representation of a sectional view of a bonescrew according to the present invention;

FIG. 36 is a schematic representation of a sectional view of a bonescrew according to the present invention;

FIG. 37 is a schematic representation of a side view of a bone screwaccording to the present invention;

FIG. 38 is a schematic representation of a side view of a bone screwaccording to the present invention;

FIG. 39 is a schematic representation of a sectional view of a bonescrew according to the present invention;

FIG. 40 is a schematic representation of a sectional view of a bonescrew according to the present invention;

FIG. 41 is a schematic representation of a sectional view of a bonescrew according to the present invention;

FIG. 42 is a schematic representation of a partially sectional view ofan orthopaedic implant system according to the present inventionincluding a bone screw, an attachment device, a catheter, and a port;

FIG. 43 is a schematic representation of a partially sectional view ofan orthopaedic implant system according to the present inventionincluding a bone screw, an attachment device, a catheter, and a port;

FIG. 44 is a schematic representation of a perspective view of anorthopaedic implant according to the present invention implanted in afemur;

FIG. 45 is a schematic representation of a sectional view of theorthopaedic implant of FIG. 44 implanted in a femur;

FIG. 46 is a schematic representation of a sectional view of twoorthopaedic implants of FIG. 44 implanted respectively in a femur and apelvis;

FIG. 47 is a schematic representation of a sectional view of anorthopaedic implant according to the present invention;

FIG. 48 is a perspective view of an orthopaedic implant according to thepresent invention;

FIG. 49 is a bottom view of the orthopaedic implant of FIG. 48;

FIG. 50 is a schematic representation of a sectional view an orthopaedicimplant according to the present invention implanted in a corporealbody;

FIG. 51 is a schematic representation of a sectional view of anorthopaedic implant according to the present invention;

FIG. 52 is a schematic representation of a sectional view an orthopaedicimplant according to the present invention implanted in a corporealbody; and

FIG. 53 is a schematic representation of a perspective view of a poroussheet to be rolled into a screw according to the present invention;

FIG. 54 is a schematic representation of an end view of the sheet ofFIG. 53 during the rolling process;

FIG. 55 is a schematic representation of a sectioned end view of thesheet of FIG. 53 after the rolling process;

FIG. 56 is a schematic representation of the sheet of FIG. 53 after therolling process;

FIG. 57 is a schematic representation of a perspective view of aspiraled band of material;

FIG. 58 is a schematic representation of a perspective view of screwlayers exploded from one another according to the present invention;

FIG. 59 is a schematic representation of a side view of a screwaccording to the present invention;

FIG. 60 is a schematic representation of a side view of a screwaccording to the present invention;

FIG. 61 is a schematic representation of a screw blank according to thepresent invention;

FIG. 62 is a schematic representation of a sheet showing raised threadsformed prior to rolling;

FIG. 63 is a schematic representation of a sheet showing threads formedby material removal prior to rolling;

FIG. 64 is a schematic representation of a plan view of a sheet showingthreads formed prior to stacking;

FIG. 65 is a schematic representation of a perspective view of a threadprior to assembly to a screw blank; and

FIG. 66 is a schematic representation of an end view of a screwaccording to the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate embodiments of the invention, and such exemplifications arenot to be construed as limiting the scope of the invention in anymanner.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, and more particularly to FIG. 1, there isshown an orthopaedic implant system 30 according to the presentinvention which generally includes an orthopaedic implant 32 implantableat a selected location within a corporeal body 34 and configured fordelivering at least one therapeutic agent 36 to the corporeal body 34.The implant 32 includes at least one reservoir 38 and a plurality ofchannels 40. The reservoir 38 is configured for receiving at least onetherapeutic agent 36 and can be configured for being refilled with thetherapeutic 36 agent after the implant 32 has been implanted in thecorporeal body 34. Channels 40 form pathways for the therapeutic agent36 to move from the reservoir 38 to a treatment site 42 relative to thecorporeal body 34. Each pathway formed by a channel 40 is an interiorspace formed by the walls of channel 40. Channel 40 can, for example,have a circular, square, or some other cross-sectional shape. Thus,channels 40 are configured for conveying at least one therapeutic agent36 from reservoir 38 to treatment site 42 relative to corporeal body 34.

FIG. 1 shows two reservoirs 38 and a plurality of channels 40 runningfrom each reservoir 38. The implant according to the present invention(i.e., implant 232) may include only one reservoir (i.e., reservoir238). The reservoirs 38 of FIG. 1 can optionally hold differenttherapeutic agents 36 at the same time; stated another way, eachreservoir 38 can hold a different therapeutic agent 36, or eachreservoir 38 can hold at least two therapeutic agents 36. Thus, theimplant according to the present invention is configured for deliveringa plurality of therapeutic agents to the corporeal body via thereservoir and the plurality of channels; examples of such implantsinclude implant 32 (FIG. 1) and implant 232 (FIG. 3). Further, implant32 may be formed such that no seal or seal cap is formed over any ofchannels 40 prior to release of any therapeutic agent 36.

A corporeal body herein means the physical body of a human being or ofan animal (i.e., a veterinary patient). Thus, a corporeal body is one offlesh and bones. The corporeal body can be alive or dead. The corporealbody can also be referred to as a patient body herein, which includesboth human and veterinary “patients”, alive or dead. “Therapeutic agent”is a general term and includes, but is not limited to, pharmaceuticalsand biologics (i.e., biological matter). Therapeutic agents can bevariously referred to herein, without limitation, as drugs,pharmaceuticals, medicinal agents, or biologics. Therapeutic agents canbe formed, for example, as a liquid, a solid, a capsule, or a bead.

Further, FIG. 1 shows that implant 32 includes a body 44 implantable atthe selected location. Body 44 defines reservoir 38 and channels 40 andincludes an exterior surface 46. The reservoir of the present inventioncan be a cavity or an enclosed pocket (closed but for channels extendingto the surface of the body of the implant) formed by the body of theimplant. The reservoir can be formed by the core (i.e., the centralinterior portion) of the body, rather than in the exterior surface ofthe body. The reservoir can occupy a substantial portion of the core butyet still have elongate channels running from the reservoir to theexterior surface. Reservoir 38 can be a cavity in body 44. Reservoir 38is not necessarily a through-hole through body 44. Channels 40 fluidlycommunicate reservoir 38 with exterior surface 46 and thereby forms thepathways for the at least one therapeutic agent 36 to move fromreservoir 38 to exterior surface 46. That is, channels 40 fluidlycommunicate reservoir 38 with exterior surface 46 and thereby convey atleast one therapeutic agent 36 from reservoir 38 to exterior surface 46.FIG. 1 shows the body 44 of the implant 32 being the implant 32 itself.

Further, FIG. 1 shows that implant 32 is formed as a hip prosthesis andthat corporeal body 34 is formed as a hip. More specifically, FIG. 1shows a sectional view of a short-term femoral hip implant 32 (which isone type of orthopaedic implant) which forms part of the upper femur(or, thighbone) and is thus load-bearing. The body 44 of the femoral hipprosthesis 32 of FIG. 1 (the body 44 and the femoral hip prosthesis 32being coextensive relative to one another and thus being the samestructural member in FIG. 1) includes a stem (the downward extendingportion of implant 32 in FIG. 1) which can be inserted into the upperfemur of a body 34 and a femoral head (the ball portion of implant 32 inFIG. 1) which is received by and mates with an acetabulum (i.e., thepatient's natural acetabulum, or a prosthetic acetabular cup). FIG. 1shows that both the stem and the femoral head include reservoirs 38 anda plurality of channels 40 running from the respective reservoirs 38 tothe exterior surface 46 of the implant 32. Depending upon the size ofreservoir 38 relative to exterior surface 46 and/or the nearness ofreservoir 38 to exterior surface 46, channels 40 can be formed as holesor apertures in body 44. In use, therapeutic agent 36 is inserted inreservoirs 38 prior to and/or after implantation of implant in body 34.Therapeutic agent 36 can then migrate into channels 40 and travel viachannels 40 to exterior surface 46 (channels 40 forming holes inexterior surface 46). Therapeutic agent 36 exits channels 40 andcontacts treatment site 42, which can be for example bone or soft tissue(it is understood that “bone” includes bone tissue). Optionally,reservoir 38 can be refilled with therapeutic agent 36 (the same or adifferent therapeutic agent 36) as implant 32 remains implanted incorporeal body 34.

The orthopaedic implant of the present invention can be, for example, aprosthesis, a nail, a plate, or an external fixation device formed as animplantable pin. FIGS. 1-16 and 20-27 shows orthopaedic implants whichare prostheses. A prosthesis is an implant that substitutes for orsupplements a missing or defective part of the corporeal body. FIG. 17shows an orthopaedic implant which is a nail. FIG. 18 shows anorthopaedic implant which is a plate. FIG. 19 shows an orthopaedicimplant which is an external fixation device with an implantable pin.

FIG. 2 shows another embodiment of the orthopaedic implant according tothe present invention. Structural features in FIG. 2 corresponding tosimilar features in FIG. 1 have reference characters raised by amultiple of 100. Short-term orthopaedic implant system 130 includes ashort-term prosthetic implant 132 and an attachment feature 150. Body144 defines reservoir 138 and channels 140 running from reservoir 138 toexterior surface 146. Attachment feature 150 is for attaching a port(not shown in FIG. 2) thereto. The attachment feature 150 can be atubular element. The attachment feature 150 and the port can be used torefill the reservoir 138 with a therapeutic agent. Upon fillingreservoir 138 with the therapeutic agent (either initially and/or as arefill) via attachment feature 150, the therapeutic agent can move fromthe reservoir 138 to the treatment site via channels 140.

FIG. 3 shows another embodiment of the orthopaedic implant according tothe present invention. Structural features in FIG. 3 corresponding tosimilar features in prior figures have reference characters raised by amultiple of 100. FIG. 3 shows a sectional view of another short-term hipimplant 232. Prosthetic implant 232 is formed as an acetabular cup,which receives a femoral head. The body 244 of the acetabular cup 232 isthe acetabular cup 232 in FIG. 3. Body 244 defines reservoir 238 and aplurality of channels 240 running from reservoir 238 to exterior surface246. Upon filling reservoir 238 with the therapeutic agent (eitherinitially and/or as a refill), the therapeutic agent moves from thereservoir 238 to the treatment site via channels 240.

FIGS. 4-8 show additional embodiments of orthopaedic implants accordingto the present invention. More specifically, FIGS. 4-8 show short-termorthopaedic implants formed as prosthetic knee implants, both femoraland tibial prosthetic knee implants. Structural features in FIGS. 4-7corresponding to similar features in prior figures have referencecharacters raised by a multiple of 100. FIGS. 4 and 5 show that the body344 of implant 332 is the femoral knee implant 332. Body 344 includes alower portion (the generally U-shaped piece in FIG. 5) and an optionalstem (the vertical, upstanding piece atop the lower portion in FIG. 5).Both the lower portion and the stem include drug reservoirs 338 and drugdelivery channels/holes 340 communicating the respective reservoir 338with exterior surface 346 to deliver the therapeutic agent(s) in thereservoirs 338 to the treatment site(s) 342. FIG. 6 shows a top view offemoral knee implant 432 similar to the implant 332 shown in FIG. 5.Channels 440 are shown as exit holes in exterior surface 446 of thelower portion. The circle in FIG. 6 represents an optional, upstandingstem 452. FIG. 7 shows a front view of short-term femoral knee implant532 marked with lettering which is more radiopaque than the implant body544 so that the letters are visible on an X-ray or fluoroscope, as shownin FIG. 7. Upon filling the reservoirs for FIGS. 5 and 6 with thetherapeutic agent (either initially and/or as a refill), the therapeuticagent can move from these reservoirs to the treatment site via channels340, 440.

FIG. 8 shows a sectional view of a short-term tibial knee implant 632according to the present invention. Structural features in FIG. 8corresponding to similar features in prior figures have referencecharacters raised by a multiple of 100. The body 644 of implant 632 isthe tibial knee implant 632. Body 644 includes a tibial tray (thegenerally horizontal piece in FIG. 8) and an optional stem (thegenerally vertical piece below the horizontal piece in FIG. 8). Both thelower portion and the stem define drug reservoirs 638 and drug deliverychannels/holes 640 communicating the respective reservoir 638 withexterior surface 646 to deliver the therapeutic agent(s) to thetreatment site(s) 642. Upon filling reservoir 638 with the therapeuticagent (either initially and/or as a refill), the therapeutic agent canmove from the reservoir 638 to the treatment site 642 via channels 640.

The implants according to the present invention shown in FIGS. 1-8 arethus short-term implants that can be used, for example, to treatinfections within a corporeal body. Such short-term or temporaryimplants allow for the delivery of therapeutic agents, such asantibiotics, directly to the bone of a corporeal body and to surroundingtissue.

A device such as a port could be used to allow for post-operativeinjections of antibiotics into the implant. (See FIG. 2). This wouldallow for the delivery of multiple antibiotics throughout treatment.Reservoirs and/or channels in the implant would allow the antibioticsfrom these injections to be delivered over a time-period from hours toweeks. (FIGS. 1-8). Injection intervals of approximately a week wouldlikely be well-accepted clinically. The drugs could be delivered to allbone and soft tissue surrounding the implant or only to specificlocations. Variations of this concept would allow for a range of jointmobility from no motion at the joint to the mobility typical of apermanent total joint. These short-term implants can be held in the bonewith a loose press-fit or with antibiotic or standard bone cement. Inthe case of bone cement, cement restrictors would also be included inthe technology to prevent cement from sealing over the drug deliveryholes.

Antibiotic cements typically provide useful local antibiotic levels fora duration of less than one week. The treatment time is frequently sixto eight weeks. However, beyond one week, the antibiotic cement implantsprovide no useful amount of antibiotics. The implant according to thepresent invention, by contrast, allows the delivery of the correct doseof antibiotics continuously for any length of time required. Through afeature such as a port attached to the implant of the present invention,the implant reservoir can be refilled as often as necessary to providethe proper drug dosing.

The implant of the present invention allows for any number ofantibiotics to be used at any time during treatment. An initialantibiotic can be used at the time of surgery. If the cell culturesindicate that a different antibiotic or dose would be more effective,that change in treatment regimen can be made in accordance with thepresent invention.

A short-term femoral hip implant, as discussed above, can include a stemand a separate head or could be a one-piece construction. Multiple sizesof stem and head size could be accommodated. A separate acetabularcomponent could be provided, as discussed above. The femoral head couldmate with a short-term acetabular component or with the patient'sacetabulum. (See FIGS. 1-3). According to the present invention, drugscan be delivered to the acetabulum through the head of the femoralcomponent if an acetabular component is not used (See FIG. 1) or throughthe acetabular component if one is used (See FIG. 3).

A short term knee implant can include a one-piece tibial component(combining the two pieces of a standard total knee replacement) and aone- or two-piece femoral component (the two-piece design would combinethe condyles and stem). The present invention provides multiple sizes oftibia components and of stem and condyles (either combined as one pieceor separate). (See FIGS. 4-8). Similar components are provided forshoulder, elbow, and other joints, according to the present invention.

Since the implants of FIGS. 1-8 are designed for short-term use, theshort-term implants of the present invention can include markings whichare both visible on the implant surface by the naked eye and visible byX-ray, as indicated above. These markings would clearly indicate thatthe implants are intended for short-term use only. (See FIG. 7).

The present invention provides an orthopaedic implant system (whethershort-term, long-term, or non-permanent implants) which provide forcontinuously delivering drugs to a point near the implant or to theentire region surrounding the implant for extended periods of time. Theimplants according to the present invention shown in FIGS. 9-16 arelong-term implants. Such implants can be used, for example, as totalhip, knee, shoulder, and elbow joints within a patient body. Thelong-term implants of the present invention have a basic similarity withthe short-term implants described above. Thus, structural features inFIGS. 9-16 corresponding to similar features in prior figures havereference characters raised by multiples of 100. Thus, similar to theshort-term implants described above, the present invention furtherprovides a long-term implant which would allow drugs to be delivereddirectly to the bone and surrounding tissue (or to any specificlocation). A device such as a port could be used to allow forpost-operative injections of drugs into the long-term implant. (See FIG.14). This would allow for the delivery of any number of drugs throughouttreatment and allow for the refilling of drugs to provide proper drugdosing throughout treatment. Reservoirs and/or channels in the long-termimplant according to the present invention would allow the drugs fromthese injections to be delivered over a time period from hours to weeks.(See FIGS. 9-16). The drugs could be delivered to all bone and softtissue surrounding the implant or only to specific locations.

FIGS. 9 and 10 show a long-term femoral hip prosthetic implant system730 according to the present invention. Structural features in FIGS. 9and 10 corresponding to similar features in prior figures have referencecharacters raised by multiples of 100. System 730 includes a long-termfemoral hip prosthetic implant 732 and a porous surface 754 attached tothe exterior surface 746. Similar to the short-term implants discussedabove, implant has a body 744 defining a drug reservoir 738 and aplurality of drug delivery channels 740 running from the reservoir 738to the exterior surface 746 so as to deliver a therapeutic agent(s) to atreatment site in the corporeal body. Porous surface 754 is configuredfor receiving bone and/or tissue ingrowth therein. Such ingrowth isshown by arrow 756 in FIG. 9. The porous surface 754 can be variouslyreferred to as a porous member, a porous pad, or a scaffold. Drugdelivery channels 740 can be routed by or through body 744 so as toavoid the ingrowth region. Stated another way, channels 740 can berouted by or through body 744 so as to avoid releasing therapeuticagents into porous surface 754. By contrast, channels 740 can be routedby or through body 744 so as to release drugs through the ingrowthporous surface 754. FIG. 9 shows channels 740 which avoid releasingdrugs into porous surface 754. Upon filling reservoir 738 with thetherapeutic agent (either initially and/or as a refill), the therapeuticagent can move from the reservoir 738 to the treatment site via channels740.

FIGS. 11 and 12 show a long-term femoral knee implant according to thepresent invention. Structural features in FIGS. 11 and 12 correspondingto similar features in prior figures have reference characters raised bymultiples of 100. The body 844 of implant 832 is the femoral kneeimplant 832. Body 844 includes a lower portion (the generally U-shapedpiece in FIG. 12) and an optional stem (the vertical, upstanding pieceatop the lower portion in FIG. 12). Both the lower portion and the steminclude drug reservoirs 838. The stem further includes drug deliverychannels/holes 840 communicating the respective reservoir 838 withexterior surface 846 to deliver the therapeutic agent(s) to thetreatment site(s) 846. The lower portion also includes at least one drugdelivery channel 840 leading from reservoir to a treatment site. Uponfilling reservoir 838 with the therapeutic agent (either initiallyand/or as a refill), the therapeutic agent can move from the reservoir838 to the treatment site via channels 840.

FIG. 13 shows a long-term femoral knee implant system 930 according tothe present invention. Structural features in FIG. 13 corresponding tosimilar features in prior figures have reference characters raised bymultiples of 100. System 930 includes a prosthetic implant 932 similarto the implant 832 of FIG. 12 but with a plurality of ingrowth poroussurfaces 954 attached to the body 944 of implant 932. Each poroussurface 954 is configured for receiving bone and/or tissue ingrowththerein. Further, while the reservoir cannot be seen in FIG. 13, a drugdelivery channel 940 leading from the drug reservoir is shown in FIG.13. The reservoir of FIG. 13 can be situated just under exterior surface946 as reservoir 838 is shown in FIG. 12. Channel 940 routes around (andthereby avoids) ingrowth pads 954. Upon filling the reservoir of implant932 with the therapeutic agent (either initially and/or as a refill),the therapeutic agent can move from the reservoir of implant 932 to thetreatment site via channels 940.

FIG. 14 shows a long-term femoral knee implant system 1030 according tothe present invention. Structural features in FIG. 14 corresponding tosimilar features in prior figures have reference characters raised bymultiples of 100. System 1030 includes a prosthetic implant 1032 similarto the implant 832 of FIG. 12. Implant 1032 is attached to a femur 1035.The system 1030 further includes an attachment feature or element 1050(such as a tubular element) for an injection port 1058, an injectionport 1058, a catheter 1060, and a reservoir 1062 remote to the implant1032. The injection port is provided for additional refilling of drugsinto the implant 1032, which includes at least one channel for routingthe therapeutic agent to the treatment site. Since an external reservoir1062 is attached to implant 1032, implant body 1044 may or may notdefine an additional internal reservoir. Upon filling the internalreservoir of implant 1032 with the therapeutic agent (either initiallyand/or as a refill) via attachment element 1050, injection port 1058,catheter 1060, and external reservoir 1062, the therapeutic agent canmove from the reservoir of implant 1032 to the treatment site via thedrug delivery channels. If implant 1032 does not have an internalreservoir, then the therapeutic agent moves to the treatment site viathe drug delivery channels from external reservoir 1062 via catheter1060, injection port 1058, and attachment element 1050.

FIGS. 15 and 16 show a long-term femoral hip implant system 1130according to the present invention. Structural features in FIGS. 15 and16 corresponding to similar features in prior figures have referencecharacters raised by multiples of 100. FIG. 15 shows long-term femoralhip implant system 1130 including a long-term femoral hip prostheticimplant 1132 and an ingrowth porous surface 1154. FIG. 16 shows a firstporous surface 1154 on the top (as oriented in FIG. 16) of the implantbody 1144 or substrate 1144 (in each of the figures, the body 1144 canalso be referred to as a substrate) and a second porous surface 1154 onthe bottom (as oriented in FIG. 16) of the body 1144. Porous surfaces1154 are configured for receiving bone and/or tissue ingrowth therein,as shown by arrow 1156. While FIG. 16 shows some space between poroussurfaces 1154 and body 1144, it is understood that this space is forillustrative purposes and that porous surfaces 1154 can be flush withbody 1144 but for any adhesive that may be used to attach surfaces 1154with exterior surface 1146 of body 1144. Each porous surface 1154includes a first side 1164 attached to exterior surface 1146 of body1144 and a second side 1166 opposing said first side 1164. Each poroussurface 1154 includes a through-hole 1168 running from first side 1164to second side 1166. Through-hole 1168 is configured for communicatingthe therapeutic agent 1136 from first side 1164 to second side 1166 andthereby for communicating the therapeutic agent 1136 to the treatmentsite 1142. The through-holes 1168 in porous surfaces 1154 lead tosurface channels 1170 and sub-surface channels 1172, respectively.Channels 1170 and 1172 can function essentially the same as channels 40in that they are drug delivery channels. FIG. 16 shows a reservoir 1138and connecting channels 1140 in broken lines; for, it is understood thatsuch a reservoir 1138 and connecting channels 1140 (connecting reservoir1138 with channels 1170 and/or 1172) may not be visible in this section,or, alternatively, that such a reservoir 1138 and connecting channels1140 can be optional (stated another way, the implant 1132 would notcontain such an interior reservoir 1138 and connecting channels 1140leading from the reservoir 1138 to the surface channels 1170 or thesub-surface channels 1172).

Further, FIG. 16 shows that exterior surface 1146 of body 1144 candefine a surface channel 1170 which is in communication with andcooperates with channel 1140 and through-hole 1168 of porous surface1154 to provide the therapeutic agent 1136 from the reservoir 1138 tothe treatment site 1142. FIG. 16 shows a plurality of such surfacechannels 1170, each of which can optionally be connected to reservoir1138 via a respective connecting channel 1140, as discussed above. Ifimplant 1132 has reservoir 1138 and connecting channels 1140, then uponfilling reservoir 1138 with the therapeutic agent (either initially oras a refill), the therapeutic agent can move from reservoir 1138 to thetreatment site via the channels 1140 and 1170. If implant 1132 does nothave reservoir 1138 and connecting channels 1140, then surface channels1170 can be filled with the therapeutic agent (either initially and/oras a refill) and the therapeutic agent moves via surface channels 1170,through through-holes 1168, to the treatment site 1142. The therapeuticagent can also be provided to the bone and/or tissue growing into poroussurface 1154.

Further, FIG. 16 shows that channels 1140 running from reservoir 1138can connect to the sub-surface channels 1172. Sub-surface channels 1172and through-holes 1168 in porous surface 1154 are aligned with andcooperate with one another to provide the therapeutic agent 1136 fromthe reservoir 1138 to the treatment site 1142. Holes 1174 (which canalso be considered as channels of the present invention, like channels40) are also provided in body 1144 leading from subsurface channels 1172to exterior surface 1146. These holes 1174 can be considered to be partof the respective channels 1140 and 1172.

FIGS. 15 and 16 thus also show an orthopaedic implant system 1130including an orthopaedic implant 1132 and a porous surface 1154. Theorthopaedic implant 1132 includes a body 1144 implantable at a selectedlocation within a corporeal body 1134 and configured for delivering atherapeutic agent 1136 to corporeal body 1134. Body 1144 of implant 1132includes an exterior surface 1146 defining a plurality of surfacechannels 1170 and, as discussed above, can have an absence of atherapeutic agent reservoir 1138. The broken lines of the reservoir 1138in FIG. 16, as stated above, indicates that the reservoir 1138 isoptional. The plurality of surface channels 1170 are configured forreceiving, holding, delivering, and being refilled with the therapeuticagent 1136 after implant 1132 has been implanted in corporeal body 1134.Orthopaedic implant 1132 is a prosthesis. Alternatively, implant 1132can be formed as a nail (FIG. 17), a plate (FIG. 18), or an externalfixation device with an implantable pin (FIG. 19). Porous surface 1154is attached to exterior surface 1146. Porous surface 1154 is configuredfor receiving at least one of bone and tissue ingrowth therein, as shownby arrow 1156. As discussed above, porous surface 1154 includes a firstside 1164 attached to exterior surface 1146 and a second side 1166opposing first side 1164. Porous surface 1154 includes a plurality ofthrough-holes 1168 running from first side 1164 to second side 1166. Theplurality of surface channels 1170 communicate and cooperate with theplurality of through-holes 1168 to provide the therapeutic agent 1136from the plurality of surface channels 1170, then to first side 1164 ofporous surface 1154, and then to second side 1166 of porous surface1154. Surface channels 1170 can be filled with the therapeutic agent(either initially and/or as a refill) and the therapeutic agent 1136moves via surface channels 1170, through through-holes 1168, to thetreatment site 1142.

Thus, the present invention could be applied to long-term implants withany type of porous coating or surface or to cemented implants. Drugscould be delivered through the porous coatings or be routed to regionswithout porous coatings (as disclosed above), depending on therequirements. (See FIGS. 9, 10, 13, 15, and 16). For delivery throughthe porous coatings, channels can be created on the surface of theimplant substrate (the solid material of the implant to which the poroussurface is attached—see FIG. 14) or below the surface, as disclosedabove relative to FIGS. 15 and 16. For surface channels, holes can bedrilled through the porous surface to the surface channels to create apath through which the drugs can be delivered. For sub-surface channels,holes must be drilled from the surface of the substrate (the body of theimplant) to the sub-surface channels to create paths for drugs to bedelivered. (See FIG. 16). This drilling can occur prior to attaching theporous coating/surface or after the porous coating/surface is attached.If this drilling occurs after the porous coating/surface is attached,the holes will be created through the porous coating/surface and thesubstrate/body surface. (See FIG. 16).

Cement restrictors can also be used according to the present inventionto prevent cement from sealing over the drug delivery holes. The presentinvention can be applied to all types of total joint implants, such astotal hip components, total knee components, total shoulder components,and total elbow components.

With regard to enhancing bone ingrowth and combating resorbtion, bonegrowth stimulators can be injected intraoperatively or postoperativelyto enhance or speed bone ingrowth into porous material (i.e., porouscoatings or pads or surfaces on total joint components, on fusiondevices (i.e., spinal fusion devices), or on bone augmentationcomponents (i.e., tibial wedges)). These drugs could also be injectedmonths to years post-operatively, using a long-term implant according tothe present invention, to combat bone resorbtion due to such causes asstress-shielding, osteolysis, or bone metabolic disorders.

With regard to oncology, the implant of the present invention wouldsimilarly allow for delivery of drugs to some or all tissue surroundingthe implant. The implants of the present invention may be cemented. Thepresent invention provides a way to route the drugs around the regionsof cement and provides a way for preventing the cement from sealing overthe drug delivery holes.

The implants according to the present invention shown in FIGS. 17-19 arenon-permanent implants. Such implants can be trauma products, such asnails, plates, and external fixation devices. The non-permanent implantsof the present invention are not necessarily limited to these devices.The non-permanent implants of the present invention have a basicsimilarity with the short-term and long-term implants described above.Thus, structural features in FIGS. 17-19 corresponding to similarfeatures in FIG. 1 have reference characters raised by multiples of 100.Thus, similar to the short-term and long-term implants described above,the present invention further provides a non-permanent implant whichwould allow drugs to be delivered directly to the bone and surroundingtissue (or to any specific location). Reservoirs and/or channels in thenon-permanent implant according to the present invention would allow thedrugs to be delivered to the treatment site and could be refilled. Anail according to the present invention is shown in FIG. 17. A plateaccording to the present invention is shown in FIG. 18. An externalfixation device according to the present invention is shown in 19.

Nails are temporary, intramedullary devices. They are typically used totreat traumatic fracture. The risk of infection can be high especiallyin the case of open fractures. The present invention would allowantibiotics to be delivered to the bone surrounding the nail as apreventative or to treat an infection if one develops.

With regard to bone growth, in the case of fractures, there areinstances in which the delivery of bone growth stimulators directly tothe region of the fracture(s) would be beneficial. This is especiallytrue in difficult cases such as non-unions, bony defects, andosteotomies. The nail according to the present invention would allow forsuch delivery bone growth stimulators directly to the region of thefracture(s).

With regard to oncology, nails can be used to treat fractures associatedwith bone tumors. They can also be used to help prevent a fracture wherecancer has weakened bone. The nail according to the present inventionprovides for localized delivery of oncological drugs in the region oftumors which may improve results in slowing/halting tumor growth. Thisability for localized delivery provided by the nail according to thepresent invention may also lessen the need/dose of systemic drugs,resulting in fewer side effects.

FIG. 17 shows an orthopaedic nail 1232 implantable in the corporealbody. Structural features in FIG. 17 corresponding to similar featuresin prior figures have reference characters raised by multiples of 100.Nail 1232 includes a body 1244 defining a reservoir 1238 and a drugdelivery channel 1240 leading from drug reservoir 1238 to exteriorsurface 1246 of nail 1232. The present invention thus provides anorthopaedic nail 1232 with a drug delivery portion, which is similar tothat, for instance, for long-term implants, such as a femoral hipimplant (such as a hip stem). This design allows drugs to be delivereddirectly to all areas of the bone or to any specific location. (FIG.17). A device such as a port could be used to allow for post-operativeinjections of drugs into the nail 1232. This would allow for thedelivery of any number of drugs throughout treatment. Reservoirs 1238and/or channels 1240 in the nail 1232 would allow the drugs from theseinjections to be delivered over a time period from hours to weeks. Thus,upon filling reservoir 1238 with the therapeutic agent (either initiallyand/or as a refill), the therapeutic agent can move from the reservoir1238 to the treatment site via channels 1240. The drugs could bedelivered to all bone tissue surrounding the implant or only to specificlocations. All types of nails could utilize this technology, includingantegrade and retrograde versions of femoral, tibial, and humeral nails.

Orthopaedic plates treat many of the same indications as nails; however,plates are applied to the outside of the bone. Plates offer the sameopportunities for delivering drugs locally. Since nails areintramedullary, they can be used to deliver drugs, according to thepresent invention, primarily to the bone tissue. Since plates areapplied to the outside of the bone, they can be used to deliver drugs,according to the present invention, to both bone and soft tissues.Examples of potential soft tissue treatments benefited by localized drugdelivery include the enhancement of soft tissue ingrowth or healing, theprevention of infection by the delivery of antibiotics, and thetreatment of nearby soft tissue tumors with localized delivery ofoncological drugs.

FIG. 18 shows an orthopaedic plate 1332 that is implantable in acorporeal body. Structural features in FIG. 18 corresponding to similarfeatures in prior figures have reference characters raised by multiplesof 100. Plate 1332 includes a body 1344 defining a reservoir 1338 and adrug delivery channel 1340 leading from drug reservoir 1338 to exteriorsurface 1346 of plate 1332. Upon filling reservoir 1338 with thetherapeutic agent (either initially and/or as a refill), the therapeuticagent can move from the reservoir 1338 to the treatment site viachannels 1340.

Thus, the drug delivery portion of plate is similar to that fororthopaedic nails according to the present invention. Plate allows drugsto be delivered directly to the bone and surrounding tissue (or to anyspecific location). A device such as a port could be used to allow forpost-operative injections of drugs into plate. This would allow for thedelivery any number of drugs throughout treatment. Reservoirs 1338and/or channels 1340 in the plate implant 1332 allow the drugs fromthese injections to be delivered over a time-period from hours to weeks.The drugs could be delivered to all bone and soft tissue surrounding theplate implant 1332 or only to specific locations.

External fixation devices are temporary implants that are used tostabilize a fracture. These external fixation devices can be used fordays to months. External fixation devices typically include several pinsfixed in the bone and extending through the skin to a rigid plate, ring,rod, or similar stabilizing device. These devices carry the added riskof infection considering that the pins extend through the skin. Bacteriacan travel along the pins directly to the soft tissue and bone. Thepresent invention can be applied to external fixation devices. Thus,antibiotics or other anti-infective agents can be provided to the boneand soft tissue surrounding the pins. (FIG. 19). An external reservoircould be used to supply/pump antibiotics to the bone and soft tissue.

FIG. 19, for instance, shows an external fixation device 1432 accordingto the present invention which is a trauma device. Structural featuresin FIG. 19 corresponding to similar features in prior figures havereference characters raised by multiples of 100. External fixationdevice 1432 includes an implantable pin 1476, a sheath 1478 coupled withpin 1476, and a reservoir 1480 coupled with sheath 1478, pin 1476defining a plurality of channels 1440. More specifically, pin 1476includes a wall 1482 defining an inner spatial area 1484 and a pluralityof drug delivery channels 1440 or holes 1440. Connected to the outercircumference of the pin 1476 is sheath 1478, which can be coaxial withpin 1476. Sheath 1478 serves to prevent drugs from exiting that portionof the external fixation device 1432 which is outside of the skin 1434.To the right (as oriented on the page of FIG. 19) of the wall of skin1434 is space that is external to the corporeal body. Further, drugreservoir 1480 is attached to sheath 1478. Drug reservoir 1480 is shapedto allow attachment of the external fixation device 1432 to externalfixation rods and/or plates (not shown). The therapeutic agent movesfrom drug reservoir 1480 to the inner spatial area 1484 of pin 1476,through channels/holes 1440 in pin wall 1482, and to the treatment site.Thus, upon filling reservoir 1480 with the therapeutic agent (eitherinitially and/or as a refill), the therapeutic agent can move from thereservoir 1480 to the treatment site 1442 via inner spatial area 1484and channel(s) 1440.

Shortcomings of temporary bone cement implants used to treat infectionsare discussed above. An additional shortcoming includes the difficultyof delivering adequate quantities of therapeutic agents through suchimplants to bone due to lack of blood flow. FIGS. 20-27 provideorthopaedic drug delivery implants which address this shortcoming. Morespecifically, FIGS. 20-21 provide therapeutic agent delivery via aremovable and replaceable cartridge. Further, FIGS. 22-26 providetherapeutic agent delivery via leaching through an implant that ispartially or totally porous. Further, FIG. 27 provides a modifiedreservoir design. The designs shown in FIGS. 20-27 can be used inshort-term, long-term, or non-permanent orthopaedic implants. Structuralfeatures in FIGS. 20-27 corresponding to similar features in priorfigures have reference characters raised by multiples of 100.

FIGS. 20 and 21 show an orthopaedic implant system 1530 including anorthopaedic implant 1532 and a cartridge 1586. More specifically, FIG.20 shows cartridge 1586 inserted in implant 1532. FIG. 21, however,shows implant 1532 with cartridge 1586 removed. Implant 1532 is formedas, for example, a short-term femoral hip prosthetic implant 1532.Implant 1532 is implanted in corporeal body 1534. Implant 1532 isdefined by its body 1544. Body 1544 defines a reservoir 1538 and aplurality of channels 1540 running from the reservoir 1538 to theexterior surface 1546 of body 1544. Cartridge 1586 is inserted into andthus received by reservoir 1538, which serves as a housing for cartridge1586. Thus, reservoir 1538, as a housing for cartridge 1586, may beshaped to matingly accommodate and connect to cartridge 1586. Reservoir1538 can be generally cup-shaped and thus be open to exterior surface1546 (and thus reservoir 1538 can essentially be a blind hole inexterior surface 1546) so as to receive cartridge 1586. Cartridge 1586contains at least one therapeutic agent 1536, which is shown in brokenlines in FIG. 20. Cartridge 1586 is configured for releasing thetherapeutic agent 1536 (shown as a circle in cartridge 1586) intoreservoir 1538 and/or at least one channel 1540 such that thetherapeutic agent 1536 moves away from reservoir 1538 in at least onechannel 1540 and thus to exterior surface 1546 of body 1544. Cartridge1586 is removable from reservoir 1538 and is replaceable with anothercartridge 1586 after implant 1532 has been implanted in the corporealbody. The first cartridge 1586 is replaced when it is empty of thetherapeutic agent (or when it has otherwise released the desired amountof therapeutic agent from the first cartridge 1586). The secondcartridge 1586, which replaces the empty first cartridge 1586, is full(or has the desired amount of therapeutic agent therein) of therapeuticagent when it is inserted into reservoir 1538 and thereby replaces firstcartridge 1586. Thus, the refilling of reservoir 1538 in system 1530occurs by replacing first cartridge 1586 with a second cartridge 1586.

Thus, system 1530 can have implant body 1544 and a replaceable portionor cartridge 1586. (FIGS. 20-21). Replaceable cartridge 1586, as stated,contains therapeutics. Upon implantation, the surgeon can decide withwhat therapeutics to fill cartridge 1586. Over time, cartridge 1586 canbe replaced with a new cartridge 1586 filled with the same therapeuticas before or a different therapeutic. Ideally, cartridge replacementwould occur as a minor outpatient procedure.

The replaceable cartridge may be optionally formed relative to theimplant. As a first option, the cartridge may be considered a distinctdevice relative to the implant but which can be directly attached to theimplant, as shown in FIG. 20. As a second option, the cartridge may beconsidered a portion of the implant which can be detached from theimplant body. As a third option, the cartridge may be a secondreplaceable implant located within the patient body away from the firstimplant (i.e., the femoral hip implant) but connected to the firstimplant, such as via a catheter. As a fourth option, the cartridge maybe a device that is situated external to the patient body, while theimplant (i.e., the femoral hip implant) is implanted in the patientbody.

FIGS. 22-26 show implants that are partially or totally porous tofacilitate therapeutic agent delivery via leaching through therespective implant. In much the same manner of powder metallurgybearings that are self-lubricating, therapeutic agents may be deliveredto the patient body from an implant that is partially or totally porous.(FIGS. 22-26). Therapeutics will leach from the porous portions of theimplant to the body. Such implants may also contain drug deliverychannels, reservoirs, and the various ways of recharging therapeutics aspreviously discussed herein. FIGS. 22 and 23 each shows a femoral hipprosthetic implant 1632 in which the entire body 1644 of the implant1632 is porous to facilitate leaching of therapeutic agents therefrom.Pores are labeled as 1690. The implant 1632 of FIG. 22, however, doesnot necessarily include a drug reservoir or drug delivery channels inaddition to the pores. Rather, it is understood that the pores and theconnections between the pores form the reservoir and the channelsaccording to the present invention. The “connections” between the pores(1) can be formed by elongate channels extending between the pores, or(2) can be formed simply by the interconnection of adjacent pores whichare adjoined and open to one another (no additional elongate channelwould extend between the pores in the second example). In use, thetherapeutic agent, such as a liquid therapeutic agent, can be pumpedinto one or more pores of implant 1632; then, the therapeutic agentleaches out through the pores (and any additional connecting elongatechannels) to the exterior surface or otherwise to the treatment site.Thus, the therapeutic agent is delivered via the pores 1690 of implant1632 to the treatment site, which can be within or outside of the pores1690. By contrast, FIG. 23 shows a drug reservoir 1638 and drug deliverychannels 1640 embedded in or defined by the body 1644 of the implant1632. Thus, upon filling reservoir 1638 with the therapeutic agent(either initially and/or as a refill), the therapeutic agent can movefrom the reservoir 1638 to the treatment site via channels 1640. FIGS.24-26 each shows a femoral hip prosthetic implant 1732 in which aportion of the body 1744 of the implant 1732 is porous to facilitateleaching of therapeutic agents therefrom. The porous portion of body1744 is labeled as 1790. The implant 1732 of FIG. 24, however, does notinclude in addition thereto a drug reservoir or drug delivery channels;but, as stated above relative to implant 1632 and FIG. 24, one or morepores, as well as the connections between the pores (“connections”, asexplained above) can form the reservoir of the channels according to thepresent invention. Thus, the therapeutic agent can be delivered via theporous portion 1790 to the treatment site, which can be within oroutside of the porous portion 1790. By contrast, the implants 1732 ofFIGS. 25 and 26 do include in addition thereto a drug reservoir 1738 anddrug delivery channels 1740. FIG. 25 shows the reservoir 1738 embeddedin or defined by the porous portion 1790 of the body 1744 of the implant1732 and drug delivery channels 1740 at least partially embedded in ordefined by the porous portion 1790 of the body 1744 of the implant 1732.Thus, upon filling reservoir 1738 with the therapeutic agent (eitherinitially and/or as a refill), the therapeutic agent can move from thereservoir 1738 to the treatment site (which can be either within oroutside of the porous portion 1790) via channels 1740. FIG. 26 showsthat the reservoir 1738 is not located in the porous portion 1790 andshows the drug delivery channels 1740 at least in part leading to theporous portion 1790. Thus, upon filling reservoir 1738 with thetherapeutic agent (either initially and/or as a refill), the therapeuticagent can move from the reservoir 1738 to the treatment site (which canbe either within or outside of the porous portion 1790) via channels1740.

FIG. 27 shows an orthopaedic implant system 1830 with a femoral hipprosthetic implant 1832 and a sponge-like or spongy material or element1892. Similar to the implants discussed above, the body 1844 of theimplant 1832 defines a drug reservoir 1838 and drug delivery channels1840 leading from the reservoir 1838 to the exterior surface 1846 of thebody 1844. The reservoir 1838 contains or houses the spongy element1892. The purpose of this material is to control dispersion of thetherapeutic agents from the reservoir 1838 into the drug deliverychannels 1840, to keep bone and tissue from growing into and filling thereservoir 1838, and/or to stiffen the implant 1832. Upon fillingreservoir 1838 with the therapeutic agent (either initially and/or as arefill) and having positioned sponge-like material 1892 in reservoir1838, the therapeutic agent can move from the reservoir 1838 (and thusalso from spongy element 1892) to the treatment site via channels 1840.Depending upon the outcome desired, the material of the sponge-likeelement 1892 can be a number of possibilities. For example, if thesponge 1892 is to remain in reservoir 1838 for a long time, then aPolyvinyl Alcohol (PVA) or Ivalon sponge, for example, can be used. Onthe other hand, if the sponge 1892 is to last a shorter amount of time,then a collagen based material (i.e., Instat, by Johnson and Johnson,for example) or a gelatin sponge (i.e., Gelfoam, by Pfizer, forexample), for example, can be used. These examples of the sponge 1892are provided by way of example, and not by way of limitation.

Any of the devices according to the present invention described abovecan include a single or multiple attachment features (such asconnections for catheters or ports) and a single or multiple sets ofreservoirs and/or channels. The same therapeutic agent can be used inall reservoirs/channels, or several therapeutic agents can be used atone time. Separate reservoirs/channels allow each of the therapeuticagents to be delivered to a specific location on the implant, ifdesired.

Any of the internal (implanted) devices according to the presentinvention described above can include an internal reservoir (containedwithin the implant) in conjunction with delivery channels/paths to allowfor short- and/or long-term delivery of the therapeutic agents. If aninternal reservoir does not exist, the implant can contain deliverychannels/paths to allow for the dispersion of the therapeutic agent.

According to the present invention, therapeutic agents can be introducedinto the delivery channels/paths and/or implant reservoir of the implantof the present invention by one or more of the following ways:

a. Direct interface between a delivery vessel (such as a hypodermicsyringe).

b. Direct attachment of a drug pump, external reservoir (external to theimplant, but can be located internally or externally to the patient),and/or port to the implant; that is, a drug pump, external reservoir,and/or port can be attached directly to the implant. A catheter can be,but is not necessarily, located between the drug pump, externalreservoir, and/or port and the implant. The therapeutic agent is thenintroduced into one of these intermediary devices by, for example, ahypodermic syringe. The therapeutic agent is then transferred to theimplant delivery channels/paths and/or implant reservoir.

c. A drug pump, reservoir, and/or port can be implanted in the body inanother location remote to the implant and/or can be connected to theimplant by, for example, a delivery tube or catheter. FIG. 28 showsschematically this option for an orthopaedic implant system. Accordingto system 1930, a reservoir 1994, a pump 1995, and a port 1996 areimplanted under the skin of a patient body 1934 remote from implant 1932and are shown connected via an implanted catheter 1998 to the reservoir1938 of the implant 1932. The reservoir 1994, pump 1995, and port 1996are thereby configured for delivering the therapeutic agent (shown byarrow 1936, which also shows the direction of travel of the therapeuticagent) from the reservoir 1994 to the treatment site 1942 via theimplant 1932. Stated another way, the pump 1995 and port 1996 cancooperate with the reservoir 1938 to deliver the therapeutic agent 1936via the catheter 1998 to the reservoir 1938 defined by the body of theimplant 1932. The body of implant 1932 can define channels, eithersub-surface or surface channels, running from reservoir 1938 to theexterior surface of implant 1932. The implant 1932 is an orthopaedicimplant, such as a prosthesis, a nail, a plate, an implanted pin of anexternal fixation device, an internal fixation device, a porous device,a bladder, a spongy element, an implant implantable in soft tissue, orany other orthopaedic implant.

d. A drug pump, reservoir, and/or port can be located external to thebody and connected to the implant by, for example, a delivery tube orcatheter. The main difference between the example of this subparagraphand the example of subparagraph c of this paragraph is that the catheterruns from one location inside the body to another location inside thebody in the example of subparagraph c of this paragraph, while thecatheter runs from outside of the body to the implant inside the body inthe example of this subparagraph. FIG. 29 shows schematically thisoption for an orthopaedic implant system. According to system 2030, areservoir 2094, a pump 2095, and a port 2096 are not implanted under theskin of a patient body 2034 but are shown connected to the reservoir2038 of the implant 2032 by a transcutaneous (passing, entering, or madeby penetration through the skin) catheter 2098. The reservoir 2094, pump2095, and port 2096 are thereby configured for delivering thetherapeutic agent (shown by arrow 2036, which also shows the directionof travel of the therapeutic agent) from the reservoir 2094 to thetreatment site 2042 via the implant 2032. Stated another way, the pump2095 and port 2096 can cooperate with the reservoir 2094 to deliver thetherapeutic agent 2036 via the catheter 2098 to the reservoir 2038defined by the body of the implant 2032. The body of implant 2032 candefine channels, either sub-surface or surface channels, running fromreservoir 2038 to the exterior surface of implant 2032. The implant 2032is an orthopaedic implant, such as a prosthesis, a nail, a plate, animplanted pin of an external fixation device, an internal fixationdevice, a porous device, a bladder, a spongy element, an implantimplantable in soft tissue, or any other orthopaedic implant.

e. A catheter runs from outside the body to the implant inside the bodybut would not include a pump, a reservoir, or a port being attached tothe outside end of the catheter (the outside end being the end oppositethe end which is attached to the implant).

The orthopaedic implants of the present invention can be applied inconjunction with any currently available designs, including porouscoatings, and can also be used in conjunction with cemented implants.

The present invention further provides a method of using an orthopaedicimplant system, such as system 30. The method includes the steps of:implanting an orthopaedic implant 32 at a selected location within acorporeal body 34, implant 32 including a reservoir 38 and a pluralityof channels 40; receiving at least one therapeutic agent 36 in reservoir38; conveying at least one therapeutic agent 36 from reservoir 38 to atreatment site 42 relative to corporeal body 34 via channels 40; anddelivering at least one therapeutic agent 42 to corporeal body 34. Asdiscussed above, the implant according to the present invention is aprosthesis, a nail, a plate, or an external fixation device with animplanted pin. Implant 32 includes a body 44 which is implanted at theselected location, body 44 defining reservoir 38 and channels 40 andincluding an exterior surface 46, channels 40 fluidly communicatingreservoir 38 with exterior surface 46 and thereby conveying therapeuticagent 36 from reservoir 38 to exterior surface 46. The method caninclude attaching a porous surface 1154 to exterior surface 1146, poroussurface 1154 receiving bone and/or tissue ingrowth 1156 therein, poroussurface 1154 including a first side 1164 attached to exterior surface1146 and a second side 1166 opposing first side 1164, porous surface1154 including a through-hole 1168 running from first side 1164 tosecond side 1166, through-hole 1168 communicating at least onetherapeutic agent 1136 from first side 1164 to second side 1166 andthereby communicating at least one therapeutic agent 1136 to treatmentsite 1142. Exterior surface 1146 can define a surface channel 1170,surface channel 1170 being in communication with and cooperating with atleast one channel 1140 and at least one through-hole 1168 and therebyproviding at least one therapeutic agent 1136 from reservoir 1138 totreatment site 1142. At least one channel 40 can be a sub-surfacechannel 1172, sub-surface channel 1172 and through-hole 1168 beingaligned with and cooperating with one another and thereby providing atleast one therapeutic agent 1136 from reservoir 1138 to treatment site1142. The method can include implanting a second reservoir 1994, a pump1995, and/or a port 1996 in corporeal body 1934 remote from implant1932, connecting second reservoir 1994, pump 1995, and/or port 1996 toreservoir 1938 of implant 1932 by at least one catheter 1998 implantedin corporeal body 1934, and delivering at least one therapeutic agent1936 to treatment site 1942 via implant 1932, catheter 1998, and secondreservoir 1994, pump 1995, and/or port 1996. The method can includeproviding a second reservoir 2094, a pump 2095, and/or a port 2096 whichis not implanted in corporeal body 2034, connecting second reservoir2094, pump 2095, and/or port 2096 to reservoir 2038 of implant 2032 byat least one transcutaneous catheter 2098, and delivering at least onetherapeutic agent 2036 to treatment site 2042 via implant 2032, catheter2098, and second reservoir 2094, pump 2095, and/or port 2096. The methodcan include inserting a cartridge 1586 into reservoir 1538, cartridge1586 containing at least one therapeutic agent 1536 and releasing atleast one therapeutic agent 1536 into reservoir 1538 and/or at least onechannel 1540 such that at least one therapeutic agent 1536 moves awayfrom reservoir 1538 in at least one channel 1540, removing cartridge1586 from reservoir 1538 after implant 1532 has been implanted incorporeal body 1534, and replacing cartridge 1586 with another cartridge1586 after implant 1532 has been implanted in corporeal body 1534. Themethod can include providing a spongy element 1892, reservoir 1838containing spongy element 1892. Body 1644, 1744 of implant 1632, 1732can be partially or completely porous. External fixation device 1432 caninclude implantable pin 1476, a sheath 1478 coupled with pin 1476, andreservoir 1480 coupled with sheath 1478, pin 1476 defining a pluralityof channels 1440. Implant may include only one reservoir. The method caninclude refilling reservoir 38 with at least one therapeutic agent 36after implant 32 has been implanted in corporeal body 34. The method caninclude delivering a plurality of therapeutic agents 36 to corporealbody 34 via reservoir 38 and channels 40 of implant 32.

FIG. 30 shows an orthopaedic implant system 3030 according to thepresent invention. Structural features in FIGS. 30-31 corresponding tosimilar features in prior figures have reference characters raised bymultiples of 100. System 3030 includes an orthopaedic implant 3032 whichis implantable at a selected location within corporeal body 3034 and isconfigured for delivering at least one therapeutic agent 3036 tocorporeal body 3034. Implant 3032 defines reservoir 3038 and channels3040. Reservoir 3038 is configured for receiving at least onetherapeutic agent 3036. Channels 3040 are configured for conveying atleast one therapeutic agent 3036 from reservoir 3038 to treatment site3042 relative to corporeal body 3034. Reservoir 3038 can receivetherapeutic agent 3036 before or after implant 3032 is implanted incorporeal body 3034. Advantageously, as with the implants describedabove, implant 3032 can be advantageously simply pumped with atherapeutic agent 3036, which can be a liquid, into the reservoir 3038,the therapeutic agent 3036 then migrating through the channels 3040 tothe exterior surface 3046 or otherwise to the treatment site 3042. Theorthopaedic implant of the present invention is an internal fixationdevice 3032 and/or a porous device 3532. Upon filling reservoir 3038with the therapeutic agent 3036 (either initially and/or as a refill,before or after implantation), the therapeutic agent 3036 can move fromthe reservoir 3038 to the treatment site via channels 3040.

An internal fixation device is a device which attaches something to theskeleton, a bone, of the corporeal body. An internal fixation deviceincludes, but is not limited to, a bone screw, a bone anchor, a bonetack, a bone graft, or a bone plug. A bone screw, for example, can beused to fix soft tissue (i.e., muscles, ligaments) to bone, or to fixbone to bone. An internal fixation device can be implanted within thecorporeal body. Such internal fixation devices may include threads foraffixation; alternatively, such internal fixation devices may includebarbs (rather than threads) to provide the affixation, may have a smoothshaft with blades at the end of the shaft (the barbs providing theaffixation), or may form a press fit with, for example, bone. Theseexamples of the device and the usages of the device are provided by wayof example and not by way of limitation.

FIG. 30 shows internal fixation device 3032 as a bone screw 3032 whichincludes an exterior surface 3046, a head 3031, and a threaded section3033. Head 3031 includes at least one channel 3041. Threaded section3033 includes at least one channel 3040. Channels 3040 fluidlycommunicate reservoir 3038 with exterior surface 3046 and thereby areconfigured for conveying at least one therapeutic agent 3036 fromreservoir 3038 to exterior surface 3046. FIG. 30 thus shows that atleast one therapeutic agent 3036 can be delivered through channels 3040in threads 3033 and/or through the delivery channel 3041 in head 3031.Implant 3032 can include only one reservoir 3038. A similar design canbe applied to, for example, a bone anchor.

As can be seen in FIG. 30, the delivery channel 3041 in the head 3031,which may be referred to as a “head channel,” defines a channel diameterHCD which is larger than interior diameters of the channels 3040 in thethreaded section 3033. Similarly, the reservoir 3038 defines a largestinterior diameter RD which may be the same as the channel diameter HCDof the head channel 3041. A tapered region 3050 is formed between thehead channel 3041 in the head 3031 and the reservoir 3038. As can beseen, the tapered region 3050 defines a tapered diameter TD which isless than the channel diameter HCD of the head channel 3041 in the head3031. The tapered region 3050 can define a minimum diameter MID adjacentthe head channel 3041 and a maximum diameter MAD adjacent the reservoir3038.

FIG. 31 shows bone screw 3032 in use in a knee. FIG. 31 showsschematically a knee joint including a femur 3035, a tibia 3037, and ajoint capsule 3039. Bone screw 3032 is placed in the femur 3035 withinthe joint capsule 3039. As such, the reservoir 3038 of bone screw 3032can be filled with at least one therapeutic agent 3036, which can thenflow through the channels 3040 and thereby be delivered directly intothe joint capsule 3039 and/or to the femur 3035.

FIG. 32 shows an orthopaedic implant system 3230 according to thepresent invention. Structural features in FIGS. 32-33 corresponding tosimilar features in prior figures have reference characters raised bymultiples of 100. System 3230 includes an internal fixation device(i.e., bone screw 3232) implanted in a bone 3241 and a second reservoir3243 implantable at the selected location within corporeal body 3234.Second reservoir 3243 includes a plurality of delivery holes 3245configured for delivering at least one therapeutic agent 3236 tocorporeal body 3234. FIG. 32 shows internal fixation device as a bonescrew 3232 including a head 3231, a threaded section 3233, and anexterior surface 3246. Second reservoir 3243 surrounds and is attachedto head 3231. Head 3231 includes an ingress channel 3247 configured forconveying at least one therapeutic agent 3236 from second reservoir 3243to reservoir 3238 of bone screw 3232. Threaded section 3233 includeschannels 3240. Channels 3240 fluidly communicate reservoir 3238 of bonescrew 3232 with exterior surface 3246 and thereby are configured forconveying at least one therapeutic agent 3236 from reservoir 3238 ofbone screw 3232 to exterior surface 3246. Second reservoir 3243 can befilled with therapeutic agent 3236 and then communicate therapeuticagent 3236 to reservoir 3238. Alternatively, reservoir 3238 can befilled with therapeutic agent 3236 and then communicate therapeuticagent 3236 to second reservoir 3243. Alternatively, therapeutic agent3236 in reservoir 3238 and second reservoir 3243 can flow from reservoir3238 to second reservoir 3243, or vice versa, depending upon the balanceof pressures in the reservoir 3238 and the second reservoir 3243. Thus,therapeutic agents 3236 can be delivered through threads 3233 of screw3232 and/or through reservoir 3238. An anchor or a bone plug can be usedin place of the bone screw 3232. Second reservoir 3243 can also bereferred to as a bladder or balloon. A syringe can be used to fill orrefill reservoir 3238 and/or second reservoir 3243. Upon fillingreservoir 3238 and/or second reservoir 3243 with the therapeutic agent3236 (either initially and/or as a refill, before or afterimplantation), the therapeutic agent 3236 can move from the secondreservoir 3243 and/or reservoir 3238 to the treatment site 3242 viachannels 3240 and/or holes 3245.

FIG. 32 shows second reservoir 3243 can be elastic and thereby beconfigured for expelling at least one therapeutic agent 3236 throughholes 3245 and/or into ingress channel 3247. That is, as secondreservoir 3243 is filled beyond its elastic yield point, the pressurecreated by second reservoir 3243 can force therapeutic agent 3236 outthrough holes 3245 and into ingress channel 3247. Therapeutic agent 3236can flow from ingress channel to reservoir 3238 and then throughchannels 3240 to exterior surface 3246 and to a treatment site 3242.Alternatively, FIG. 33 shows second reservoir 3243 can be rigid (notelastic) and can form a permeable membrane configured for controllablyreleasing at least one therapeutic agent 3236 therefrom. System 3230 inFIG. 33 is substantially identical to system 3230 in FIG. 32 but forsecond reservoir 3243, as explained herein. Arrows in FIG. 33 showtherapeutic agent 3236 flowing through the permeable membrane of secondreservoir 3243. As a permeable membrane, second reservoir 3243 can bemade of a material that inherently has permeability without having toform holes therein in a separate manufacturing step. Upon fillingreservoir 3238 and/or second reservoir 3243 with the therapeutic agent3236 (either initially and/or as a refill, before or afterimplantation), the therapeutic agent 3236 can move from the secondreservoir 3243 and/or reservoir 3238 to the treatment site 3242 viachannels 3240 and/or holes 3245.

FIG. 34 shows an orthopaedic implant system 3430 according to thepresent invention. Structural features in FIG. 34 corresponding tosimilar features in prior figures have reference characters raised bymultiples of 100. System 3430 includes an internal fixation device(i.e., bone screw 3432) implanted in a femur 3435 of a knee jointincluding the femur 3435 and the tibia 3437. Skin of corporeal body 3434is also shown in FIG. 34. System 3430 further includes a secondreservoir 3462 and a tubular element 3498 (i.e., catheter). Secondreservoir 3462 is implanted within corporeal body 3434 remote from bonescrew 3432. Tubular element 3498 is implanted within corporeal body3434. Bone screw 3432 includes an exterior surface 3446. Secondreservoir 3462 is coupled with bone screw 3432 via tubular element 3498and is thereby configured for delivering at least one therapeutic agentto exterior surface 3446 via tubular element 3498, the reservoir, andthe channels. The reservoir and channels of bone screw 3432 are notshown in FIG. 34, but it is understood that bone screw 3432 includes areservoir and channels like those of bone screw 3032. Tubular element3498 can be coupled with the head of bone screw using, for example, aninterference fit; an alternative way of attachment is shown below. FIG.34 shows bone screw 3432 placed inside the joint capsule 3439.Therapeutic agents are contained in second reservoir 3462, are deliveredto screw 3432, and are eluted or otherwise passed from screw 3432 intothe femur 3435 and/or the joint capsule 3439. Second reservoir 3462 canbe placed within soft tissue, rather than at the knee where the bone isclose to the skin. Upon filling reservoir 3462 with the therapeuticagent (either initially and/or as a refill, before or afterimplantation), the therapeutic agent can move from the reservoir 3462 tothe treatment site via bone screw 3432. Second reservoir 3462 can befilled prior to or after implantation of reservoir 3462 and/or bone3432, initially and/or as a refill.

FIGS. 9, 13, 15-16, 22-26, 35-36, 40, 44-49, and 51 show porous devicesaccording to the present invention. The porous device according to thepresent invention can be a screw, as discussed below, but can be otherorthopaedic implants as well. For instance, the porous device can beother internal fixation devices. Further, the porous device according tothe present invention can be natural or artificial bone grafts.

Thus, the present invention further provides porous screws and screwsthat can deliver therapeutic agents. Further, the present inventionprovides a porous screw for attaching various soft tissues to bone,and/or for attaching bone to bone, and/or for delivering therapeuticagents (for example biologics or drugs) to soft tissue and/or bone.Potential uses include, but are not limited to, ACL and PCLreconstruction, medial collateral ligament repair, lateral collateralligament repair, posterior oblique ligament repair, iliotibial bandtenodesis reconstruction, patellar ligament and tendon repair, pediclescrews for spine repair, bone fracture fixation screw, and drug elutingimplant (non-load bearing) for delivery of therapeutics.

An embodiment of the present invention provides an orthopaedic screwhaving a plurality of regions, at least one of which may be porous. Theorthopaedic screw includes a head, a tip and at least one thread. Theporosity of the screw of the present invention can vary within the partor region, including changes in pore shape, size and density. Thesecharacteristics can vary along the length of the screw axis and/orradially (from the outer diameter to the axis).

The orthopaedic screw of the present invention may further include atleast one solid region formed of any implantable polymer, reinforcedpolymer or metal. The solid region of material may be, for example, atthe outer portion of the threads and the leading tip of the screw due tothe high stresses present during insertion. The solid region may furtherinclude the head of the orthopaedic screw of the present invention.

The materials to create the orthopaedic screw of the present inventioncan be any implantable polymer, metal or ceramic, or any combinationthereof. Possible polymers include polyetheretherketone (PEEK),polyetherketone (PEK), polyaryletherketone (PAEK), polyethylene, andresorbable polymers such as polylactic acid (PLA) and polyglycolic acid(PGA).

The thread of the orthopaedic screw of the present invention may becontinuous or discontinuous and be a single or multiple lead thread. Theinventive screw may further be cannulated or non-cannulated.

The orthopaedic screw of the present invention may further be used tolocally deliver therapeutic agents that promote positive tissue response(e.g. increased growth rate, decreased inflammatory response). Suchtherapeutic agents include, but are not limited to, hydroxyapatite,drugs and biologics.

Another embodiment of the orthopaedic screw of the present inventionprovides for immediate delivery of a therapeutic agent through channelsand/or holes and reservoirs for long-term delivery of a therapeuticagent. Access to the delivery channels, holes and/or reservoirs may begained by provision of a self-sealing polymer diaphragm which can allowfor direct interface with a needle at the time of surgery ofpost-surgery. Alternatively, a removable cap made of PEEK or otherimplantable material may provide access to and seal the medicinedelivery features of the inventive screw.

An advantage of the present invention is that the porous nature of theinventive orthopaedic screw and the ability to deliver therapeuticagents to the surrounding tissue promotes successful tissue integration.Such local delivery of therapeutic agents can aid in such issues asimproving the attachment strength of soft tissue to bone inreconstructive surgeries, improving the attachment strength of bone toscrew, and strengthen bone in osteoarthritic or osteoporotic patients.Another advantage is that the orthopaedic screw of the present inventioncan effectively be utilized for long term or short term delivery oftherapeutic agents. Another advantage is that the therapeutic agent canbe pre-loaded into the device at the factory or loaded by the surgeonbefore, during, or after surgery.

The present invention provides a device which can have a porous natureand which has the ability to deliver therapeutic agents. The porousnature of the device of the present invention and the ability of thedevice of the present invention to deliver therapeutic agentstherethrough promotes successful bone and/or soft tissue integration.

The present invention provides a screw that is porous and/or can delivertherapeutic agents to the surrounding tissue. The materials to createthis screw can be any implantable polymer, metal or ceramic orcombinations of these. Possible polymers include PEEK(Poly(etheretherketone)), PEK (Poly(etherketone)), PAEK(poly(aryletherketone)), polyethylene, and resorbable polymers such asPLA (Poly(lactic acid)) and PGA (poly(glycolic acid)). Likely firstcandidates are PEEK, reinforced PEEK (reinforcing materials include butare not limited to carbon fiber/particles/nanotubes, barium sulfate,zirconia) and titanium/titanium alloys. The screw of the presentinvention can include the ability to deliver therapeutic agents (such asdrugs or biologics) to the surrounding tissue. The therapeutic agent canbe selected by the surgeon before the surgery, at the time of surgery,or at any point in time thereafter. In addition, the therapeutic agentcan be pre-loaded into the device at the factory through currentlyacceptable practices or loaded by the surgeon before, during, or aftersurgery (as a follow-up procedure).

The screw of the present invention can be porous but does not need to beporous.

Structural features in FIGS. 35-43 and 53-66 corresponding to similarfeatures in prior figures have reference characters raised by multiplesof 100. Screw 3532 of the present invention can be fully porous or haveselect regions of solid material. FIG. 35 shows a completely porousscrew. The reservoir of screw 3532 of the present invention is formed byone or more pores 3590. The channels 3540 of screw 3532 of the presentinvention are formed by the pores 3590 themselves; more specifically,the interconnected pores 3590 form the channels 3540 to the exteriorsurface 3546 of screw 3532. Such a porous screw can be pumped, forinstance, with a therapeutic agent, such as a liquid therapeutic agent;the therapeutic agent can then leach out through the interconnectedpores 3590 to the exterior surface 3546 of implant to a treatment site3542.

Further, FIG. 36 shows that screw 3532 may include porous region 3590and a solid region 3593 of material at the outer portion of threads 3533and leading tip 3549 of screw 3532. The solid region 3593 of material atthe outer portion of threads 3533 and leading tip 3549 of screw 3532 maybe desired due to the high stresses these regions can see during screwinsertion (see FIG. 36). In addition, a very rough porous structure onthe outer portion of the threads can cause insertion of the screw to bedifficult due to its potential to grab versus slide past or cut throughbone/soft tissue. Head 3531 of screw 3532 may be solid. This solidmaterial can be formed of any implantable polymer, reinforced polymer,or metal. To fill or partially fill implant 3532, an attachment device,a catheter, and a port can be used, for example, as shown in FIGS. 42and 43.

Thread 3533 can be continuous (see FIG. 37) or discontinuous (see FIG.38) and be a single or multiple lead thread. The porosity of the screw3532 can vary within the region(s), including changes in pore shape,size, and density. These characteristics can vary along the length ofthe screw axis and/or radially (from the outer diameter to the axis).Another way of improving integration of the surrounding tissue is todeliver therapeutic agents that promote positive tissue response (e.g.increased growth rate, decreased inflammatory response). The orthopaedicscrew of the present invention can be used to locally deliver suchtherapeutic agents to the tissue surrounding the device. Such localdelivery of therapeutic agents can aid in such issues as improving theattachment strength of soft tissue to bone in reconstructive surgeries,improving the attachment strength of bone to the screw, and strengthenbone in osteoarthritic or osteoporotic patients. Therapeutic agentsinclude, but are not limited to, hydroxyapatite, drugs, and biologics.

Screws allowing for localized delivery of therapeutic agents, accordingto the present invention, can be, but need not be, porous. Porous screwsaccording to the present invention can, but need not, allow forlocalized delivery of therapeutic agents.

Screw 3532 can contain reservoirs 3538 for the long-term delivery of thetherapeutic agents, as illustrated in FIG. 40 and/or channels/holes3540, as illustrated in FIG. 39, for immediate, local delivery oftherapeutic agents. Screw 3532 can further include a plurality ofinterconnected pores 3590 allowing for local delivery of a therapeuticagent to the surrounding tissue, as shown in FIG. 40. These options aredescribed as follows:

-   1. Long term delivery.    -   a. Reservoirs. One or more reservoirs 3538 can allow for the        long-term (hours to weeks) delivery of the therapeutic agents.        Access to delivery channels 3540, reservoir 3538, etc. of screw        3532 is gained by several ways including:        -   i. Self-sealing polymer diaphragm 3551 can allow for direct            interface with a needle at the time of surgery or            post-surgery (see FIG. 40).        -   ii. A removable cap 3553 made of PEEK or another implantable            material can also provide access to the therapeutic agent            delivery features and seal these features after delivery of            the therapeutic agent (FIG. 41). A tool that facilitates            insertion of the screw could also aide in assembling cap            3553 to the screw.    -   b. Connect to another device. Access to the therapeutic agent        delivery features of the screw can be provided by interfacing        screw 3532 with a device designed to deliver therapeutic agents        from subcutaneous to elsewhere in the body (e.g. a port that is        frequently used to deliver therapeutic agents from sub-skin to a        vein deeper in the chest cavity). The last option can include        attachment feature 3555 on screw 3532 that directly interfaces        with port 3596, interfaces with catheter 3598 (which interfaces        with the port 3596), or interfaces with an additional component,        which can be attached to screw 3532 to interface with port 3596        or catheter 3598. (See FIGS. 42 and 43). FIG. 43 shows an        alternative attachment feature 3555. Port 3596 can have a septum        (the center circle of port 3596) for receiving an injection of a        therapeutic agent.-   2. Immediate delivery. No reservoir is required for this approach,    although a reservoir can be provided. The access means of the    reservoir design above (self-healing or self-sealing polymer    diaphragm 3551 and removable cap 3553) can also be used to access    delivery channels 3540 in this design. This design can also include    a simple interface with a delivery tool. An example of this is a    simple slip fit between a delivery needle and the screw's cannula.

A given screw can contain any or all of these options. Upon fillingreservoir 3538 of screw 3532 (whether screw 3532 is porous or not) withthe therapeutic agent (either initially and/or as a refill, before orafter implantation), the therapeutic agent can move from the reservoir3538 (or from the pores where the filling with the therapeutic agentoccurred) to the treatment site via bone screw 3532.

Cannulation.

The screws can be cannulated or non-cannulated.

Sections (A) through (E) are discussed immediately below. These sectionsare as follows: (A) manufacturing options for making the porous screwaccording to the present invention; (B) how to bond parts containingpolymer(s); (C) how to bond metal/metal alloy parts; (D) manufacturingoptions for making screw threads of a screw according to the presentinvention; and (E) and manufacturing options for cannulation accordingto the present invention. Sections (A) through (E) are discussed inreference to forming a screw according to the present invention. It isunderstood, however, that the discussion can be applied or adapted asnecessary to other internal fixation devices and/or porous devices.

A. Porous Structure—Manufacturing Options According to the PresentInvention

The porous structure of the present invention can be manufactured usinga variety of methods. These manufacturing options according to thepresent invention include seven options as follows:

-   1. Rolled. A porous sheet can be, for example, rolled into a screw.    This is essentially the reverse of making a radial, spiral cut that    is parallel to the axis of the screw. Layers of different materials    can be combined in this process. This process involves the    following:    -   a. Make a porous sheet with holes in a pattern so that they line        up when rolled.    -   b. Roll sheet (see FIGS. 53-56. FIG. 53 shows a porous sheet        5332 according to the present invention to be rolled into a        screw. FIG. 54 shows an end view of sheet 5332 during the        rolling process. FIG. 55 shows a sectioned end view of the final        product, formed as a screw 5332. FIG. 56 shows the sheet 5332        with a center 5365 formed as a cannula (an open hole through the        screw axis), or a porous rod, or a solid rod.). This step can be        performed with or without the aid of a center mandrel or rod.        -   1. The sheet can be rolled without the aid of any center            mandrels. This can create a cannulated screw. A            biocompatible pin/rod can be inserted in any center hole and            bonded to the screw to create a non-cannulated screw.        -   2. The sheet can be rolled around a removable mandrel. This            can create a cannulated screw. A biocompatible pin/rod can            be inserted in any center hole and bonded to the screw to            create a non-cannulated screw.        -   3. Alternately the sheet can be rolled around and bonded to            a biocompatible rod, creating a non-cannulated screw.    -   c. Bond the rolled material.-   2. Spiraled layers. This method is similar to the rolled approach,    but this method involves bands of material that are wrapped around    one another. The main difference between this method and that of    rolling is that in this method, the bands of material 5732 translate    along the axis while they are wrapped (see FIG. 57. FIG. 57 shows an    example of a spiraled band of material, the material not having    pores). Bands of several materials can be combined and intertwined.    All bands can have the same direction and pitch of winding or    different directions and pitches. These bands can be wrapped around    a mandrel 5765 that is later removed to aid in bonding and to create    a cannula. They can also be wrapped around a pin 5765 which they are    then bonded to, creating a non-cannulated screw. An alternate option    for creating a non-cannulated screw is to create the screw with or    without the aid of a mandrel, then insert and bond a pin within the    center hole of the screw.-   3. Layered/stacked. Make a number of layers that are stacked and    bonded to create the screw. These layers can be parallel to one    another. The faces of the layers are perpendicular to the axis of    the screw, parallel to it, or any other angle of orientation. To    reduce secondary operations, alignment of one layer to another may    be desirable. Alignment of layer to layer can be achieved by such    ways as alignment fixtures that line up the center cannula (if the    screw is cannulated) of each layer to one another (by way of a pin    for example), fixtures or implant components/features that align    pore or thread features to one another, or fixtures or implant    components/features that align features on the outer diameter of    each layer to one another. Features can also be created within a    given layer to aid in alignment and/or assembly (such as grooves and    mating protrusions). FIGS. 58-60 show the stacked manufacturing    method. FIG. 58 shows layers 5867 of the screw 5832 exploded from    one another and stacking in the direction of the arrows. FIG. 59    shows a side view of screw 5932 with stacked layers 5967    perpendicular to the longitudinal axis of screw 5832. FIG. 60 shows    a side view of screw 6032 with stacked layers 6067 parallel to the    longitudinal axis of screw 6032.

Note: The holes shown in FIGS. 58-60 can be created by, for example,laser cutting, punching, etching, electrical discharge machining, plasmaetching, electroforming, electron beam machining, water jet cutting,stamping, or machining. For polymer based materials, they can be createdas the sheets are created by, for example, extruding, injection molding,or hot stamping.

-   4. Dissolvable material.    -   a. One method involves creating a mixture of powdered        implantable material (e.g.

PEEK) and a powder (e.g. salt) that is soluble in something in which theimplantable material is not soluble (such as water, isopropyl alcoholfor the PEEK example). The mixture is then heated to bond theimplantable particles together. Pressure can also be applied to aid inthe bonding of particle to particle. Heat can be created by convectionor other ways (such as coating the powder with a material that absorbs agiven range of energy waves—such as laser waves—and causes heating.(e.g. Clearweld coating by Gentex® Corporation)). Finally, dissolve awaythe filler to create the porous implantable material. This method cancreate net shape parts or raw material shapes from which individualparts can be created.

-   -   b. Another method involves mixing an implantable polymer with a        dissolvable material such as described above. The mixture is        then pelletized and then injection molded to an intermediary or        the final part shape. The filler is dissolved away to create the        porous implantable polymer.

-   5. Stereolithography.

-   6. Laser or electron beam sintering of powdered material.

-   7. A combination of the above methods: for example, using the    dissolvable method to create microporous sheets of PEEK, then    stamping larger pores and stacking to create a screw.

B. How to Bond Parts Containing Polymer(s)

Options for Bonding Processes

-   1. Heat. Heat can be generated in several ways:    -   a. Ultrasonic welding—use ultrasonic waves to create heat at the        interface of layers.    -   b. Heat staking—use a heated tool to cause melting between the        layers.    -   c. Vibratory welding.    -   d. Laser welding.    -   e. Convection—use an oven to create heat to cause bonding.    -   f. Intermediary layer—for example, use a material that can        absorb energy waves that pass through the polymer (for example        PEEK) without causing damage. The absorbed energy will cause        localized heating. An example of such a coating is Clearweld by        Gentex® Corporation. The laser waves that Clearweld absorbs pass        through the PEEK without causing damage, allowing the layers to        be melted together without large scale damage to the PEEK.-   2. Chemical.    -   a. Adhesives—a secondary material (such as adhesive) can be used        to bond the material.    -   b. Solvent bonding—a material in which the polymer or reinforced        polymer is soluble can be applied to the sheet surfaces allowing        multiple surfaces to be bonded to one another.    -   c. Overmolding—overmolding of the polymer or reinforced polymer        can provide a chemical bonding-   3. Mechanical.    -   a. Overmolding—overmolding of a polymer or reinforced polymer        can create a mechanical lock between components on a micro or        macro scale (microscale—the molded material locks with surface        asperities of the existing material. Macroscale—features such as        tongue-groove connections or undercuts). The overmolded material        can be a separate component from the layers or one layer can be        overmolded onto another layer.    -   b. Features are provided within the layers or by a separate        component which provides a mechanical lock—e.g. a pin, snap lock        connection, dove-tail, tongue-groove, rivet, melting tabs to        create a mechanical lock, etc.    -   c. Some adhesives provide a mechanical bond in addition to or        instead of a chemical bond.-   4. Combinations of any/all of the above methods.

Order of Processes

-   1. Bond all layers together at once—especially attractive for    methods utilizing energy waves to trigger bonding (e.g. Clearweld    coating by Gentex® Corporation or ultraviolet light curable    adhesives).-   2. Simultaneously bond and roll/stack layers at once—again, may be    especially attractive for methods utilizing energy waves to trigger    bonding (e.g. if light cannot penetrate all layers of a rolled    design in order to activate an adhesive, the rolling operation could    take place in a light box allowing for a continuous rolling and    adhesive curing operation.-   3. Roll/stack layers and bond in increments. This could add a single    layer at a time or multiple layers.

C. How to Bond Metal/Metal Alloy Parts

Options for Bonding Processes

-   1. Heat.    -   a. Laser welding—layers can be laser welded in a number of        locations. Two or more layers or wraps of material can be welded        together at once depending on the size of the part and alignment        of the pores (the laser can access several layers to be bonded        through the porosity).    -   b. Spot welding—traditional spot welding can be used to bond two        or more layers/wraps of material.    -   c. Diffusion bonding/sintering.    -   d. Vibratory welding.    -   e. Ultrasonic welding.-   2. Adhesives.-   3. Mechanical ways. Features are provided within the layers or by a    separate component which provides a mechanical lock—e.g. a pin, snap    lock connection, dove-tail, tongue-groove, rivet, melting tabs to    create a mechanical lock etc.-   4. Overmolding with an implantable polymer. Overmolding of PEEK or    another implantable polymer can create a mechanical lock between    components on a micro or macro scale (microscale—the molded material    locks with surface asperities of the existing material.    Macroscale—features such as tongue-groove connections or undercuts).    The overmolded material can be a separate component from the layers    or one layer can be overmolded onto another layer.

Order of Processes

As with the polymer materials discussed above, two or more layers ofmetal can be bonded during increments or as a continuousstacking/bonding process.

D. Making Threads—Manufacturing Options According to the PresentInvention

-   1. Form the threads after the layers have been bonded to create a    screw blank (see FIG. 61.

FIG. 61 shows the screw blank 6132 of the stacked type.).

-   -   a. Machine the threads    -   b. Hot form the threads with a mold

-   2. Form threads in the sheets prior to bonding.    -   a. Rolling method: The material will not actually create the        complete thread shape until the sheets are formed into the final        shape. Continuous or discontinuous threads can be created.        Design options for this method include creating raised material        that forms the threads (see FIG. 62) or removing material to        leave the thread material (see FIG. 63). The raised material in        the first method can be created by way of machining, laser        ablation, hot stamping, hot or cold forming, chemical etching,        electro-discharge machining and similar methods. The material of        the second method can be removed by way of machining, laser        cutting, stamping, etching, punching, electro-discharge        machining, water jet cutting, electron beam machining or other        means. FIG. 62 shows a sheet 6232 according to the present        invention having raised threads 6233 formed prior to rolling.        FIG. 62 shows raised material to form threads 6233. The bottom        portion of FIG. 62 (below the broken lines) shows a top view of        the sheet 6232 prior to rolling. The top portion of FIG. 62        (above the broken lines) shows a side view (more precisely, an        edge view) of the sheet 6232 prior to rolling. The threads of        the bottom portion and top portion of FIG. 62 align with one        another per the broken lines, which show the correspondence        between the bottom and top portions of FIG. 62. FIG. 63 shows a        sheet 6332 showing threads 6333 formed by material removal prior        to rolling. In FIG. 63, D is screw major diameter, t is sheet        thickness, and p is screw pitch. FIG. 63 shows a vertical tab T        and a horizontal tab T (as oriented on the drawing page), one or        both of which may be removable. Porous region is labeled as        6390, the circles showing pores. An open area (no material) is        labeled as A. The area labeled as B shows a thread region which        may be solid or porous or may gradually change from solid to        porous starting at the tab and moving inward to the porous        region 6390. The sheet 6332 may be rolled and bonded to make        screw 6332.    -   b. Stacking method: Continuous or discontinuous threads can also        be created by this method. The ‘ears’ of material in each layer        6467 form the threads 6433 when the layers are stacked (see FIG.        64). These can be created by way of machining, hot stamping, hot        or cold forming, dies/punches, chemical etching,        electro-discharge machining and similar methods. FIG. 64 shows        preformed threads 6433 in one layer 6467 of a stacked part.        Stated another way, FIG. 64 shows a sheet showing threads 6433        formed prior to stacking.

-   3. Add separate threads—Threads can be formed separately and    attached to the screw blank.

Separate threads can look like 6533 in FIG. 65. The material for thesethreads can include: biocompatible polymers, reinforced biocompatiblepolymers and/or biocompatible metals. The attachment ways for thesethreads include:

-   -   a. Mechanical attachment—press/interference fit, tabs.    -   b. Overmolding—mold the solid, porous, or reinforced polymer        screw inside of the solid threads or mold the porous, solid or        reinforced polymer threads onto the already formed screw.    -   c. Adhesive or solvent bonding.

E. Cannulation—Manufacturing Options According to the Present Invention

With any of the manufacturing methods, screws can be created with orwithout a cannula.

-   1. Cannulated.    -   a. Rolling method. In this method, it can be desirable to wind        the material around a mandrel that is at the center of the        screw, running along its axis. This mandrel can be removed to        leave an open cannula (see FIG. 66). FIG. 66 shows a screw 6632        with an open cannula after the mandrel is removed during the        rolling method.    -   b. Layered method. A center hole at the axis of each layer is        created to form the cannula when they are stacked together.-   2. Non-cannulated.    -   a. Rolled method.        -   i. The sheet can also be bonded to the mandrel, with the            mandrel forming a portion of the implant. This mandrel can            be solid or porous and of any implantable material such as            PEEK or titanium.        -   ii. In addition, the material can be formed around a            removable mandrel, creating a cannula. This cannula can be            then be filled with a biocompatible material that is            attached/bonded to the screw.    -   b. Layered method. The layers that are stacked to create the        screw can have solid material in place of the holes that would        create the cannula. Alternately, they can have cut-outs creating        the cannula and this cannula can be filled with a biocompatible        material that is attached/bonded to the screw.

Structural features in FIGS. 44-49 corresponding to similar features inprior figures have reference characters raised by multiples of 100. Theporous device can also be formed as a bone graft. It is understood that“bone graft” refers to either a natural bone graft or an artificial bonegraft. A natural bone graft is taken from an alive donor or a deaddonor. A natural bone graft can be taken from the corporeal body whichis to receive the implanted bone graft, taken from another human being,or taken from an animal (such as autografts, allografts, andxenografts). FIGS. 44-45 show a natural bone graft, formed as a boneplug 4432, which is implanted in the distal end of the femur 4435 fordelivering at least one therapeutic agent 4436. The bone plug 4432 isplaced in the distal intramedulllary canal of the femur 4435. The boneplug 4432 includes an artificially formed reservoir 4438, artificiallyformed channels 4440, and an exterior surface 4446. It is understoodthat such a natural bone plug 4432 likely has naturally formed pores,which possibly can receive bone and/or soft tissue ingrowth therein (asshown by arrow 4456). FIG. 46 shows two such bone plugs 4432 fordelivering therapeutic agent(s) 4436. The bone plugs 4432 are shownplaced in bone near the joint space. FIG. 46 shows the hip joint capsule4439. One bone plug 4432 is implanted in the pelvic bone 4457. The otherbone plug 4432 is implanted in the femoral head of the femur 4435. Boneplug 4432 can deliver therapeutic agents(s) directly within the jointcapsule 4439 and/or to the bone 4435, 4457. FIG. 47 shows a bone graft4732 without artificially formed reservoir and channels; rather, bonegraft 4732 in FIG. 47 includes a plurality of naturally formed pores4790 which form the reservoir and the plurality of channels. Thereservoir 4738 is formed by one or more such pores 4790. The channels4740 are formed by the interconnection between the pores 4790 to theexterior surface 4746. FIG. 47 shows bone and/or soft tissue ingrowth byarrow 4756. FIGS. 48-49 show an artificially formed bone graft 4832,which can also be referred to as a porous surface or scaffold. Thescaffold 4832 is shown in a simplified form, for illustrative purposes.The scaffold 4832 has two layers, each layer having a plurality of pores4890. The pores 4890 of each layer are offset with each other in a waythat still forms pathways or channels 4840 extending between the top andbottom sides of the scaffold. One or more pores 4890 of the scaffold4832 can form the reservoir 4838, the interconnected pores 4890 alsoforming the channels 4840. Bone and/or soft tissue ingrowth is shown byarrow 4856. FIG. 49 shows the bottom side of the scaffold 4832 shown inFIG. 48. Thus, the dashes in FIG. 49 show the pores 4890 from the toplayer of the scaffold 4832 in FIG. 48. The circles which have a solidline defining its entire perimeter are pores 4890 formed in the bottomlayer of the scaffold 4832 shown in FIG. 48. The scaffold 4832 can bemade of metal, polymer, or ceramic. Further, FIGS. 48-49 show an inflowof a liquid or fluid therapeutic agent (using arrow 4836) which isprovided (i.e., by a pumping action) to the implant 4832, thetherapeutic agent 4836 then leaching out through the pores 4890 and/orchannels 4840 to the exterior surface 4846 of the implant 4832 to thetreatment site. Upon filling reservoirs of implants 4432, 4732, 4832with the therapeutic agent (either initially and/or as a refill, beforeor after implantation), the therapeutic agent can move from thereservoir to the treatment site via the implant 4432, 4732, 4832.

The present invention further provides a method of using an orthopaedicimplant system 3030, 3530. The method includes the steps of: providingan orthopaedic implant 3032, 3532 defining a reservoir 3038, 3538 and aplurality of channels 3040, 3540, implant 3032, 3532 being at least oneof an internal fixation device 3032 and a porous device 3532; implantingimplant 3032, 3532 at a selected location within corporeal body 3034,3534; receiving at least one therapeutic agent 3036, 3536 in reservoir3038, 3538; conveying at least one therapeutic agent 3036, 3536 fromreservoir 3038, 3538 to a treatment site 3042, 3542 relative tocorporeal body 3034, 3534 via channels 3040, 3540; and delivering atleast one therapeutic agent 3036, 3536 to corporeal body 3034, 3534.

Internal fixation device 3032 includes an exterior surface 3046, theplurality of channels 3040 fluidly communicating reservoir 3038 withexterior surface 3046 and thereby conveying at least one therapeuticagent 3036 from reservoir 3038 to exterior surface 3046. Internalfixation device 3032 is a bone screw 3032 including an exterior surface3046, a head 3031, and a threaded section 3033, head 3031 including atleast one channel 3040, threaded section 3033 including at least onechannel 3040, channels 3040 fluidly communicating reservoir 3038 withexterior surface 3046 and thereby conveying at least one therapeuticagent 3036 from reservoir 3038 to exterior surface 3046.

The method can further include implanting a second reservoir 3243 at theselected location within corporeal body 3234, delivering at least onetherapeutic agent 3236 to corporeal body 3234 via a plurality of holes3245 in second reservoir 3243, internal fixation device 3232 includingan exterior surface 3246, second reservoir 3243 at least partiallysurrounding and being attached to internal fixation device 3232,internal fixation device 3232 including an ingress channel 3247conveying at least one therapeutic agent 3236 from second reservoir 3243to reservoir 3238 of internal fixation device 3232, plurality ofchannels 3240 fluidly communicating reservoir 3238 of internal fixationdevice 3232 with exterior surface 3246 and thereby conveying at leastone therapeutic agent 3236 from reservoir 3238 of internal fixationdevice 3232 to exterior surface 3246. Internal fixation device 3232 canbe a bone screw 3232 including a head 3231, a threaded section 3233, andan exterior surface 3246, second reservoir 3243 surrounding and beingattached to head 3231, head 3231 including ingress channel 3247conveying at least one therapeutic agent 3236 from second reservoir 3243to reservoir 3238 of bone screw 3232, threaded section 3233 includingchannels 3240, channels 3240 fluidly communicating reservoir 3238 ofbone screw 3232 with exterior surface 3246 and thereby conveying atleast one therapeutic agent 3236 from reservoir 3238 of bone screw 3232to exterior surface 3246. Second reservoir 3243 can be elastic andthereby expel at least one therapeutic agent 3236 through holes 3245and/or into ingress channel 3247. Second reservoir 3243 can be rigid andform a permeable membrane which controllably releases at least onetherapeutic agent 3236 therefrom.

The method can further include implanting a second reservoir 3462 withincorporeal body 3434 remote from internal fixation device 3432,implanting a tubular element 3498 within corporeal body 3434, secondreservoir 3462 coupled with internal fixation device 3232 via tubularelement 3498 and thereby delivering at least one therapeutic agent 3436to an exterior surface 3446 of internal fixation device 3434 via tubularelement 3498, reservoir of device 3432, and channels of device 3432.Internal fixation device 3432 is a bone screw 3432.

Porous device 3532 is partially porous (FIG. 36) or completely porous(FIG. 35). Porous device can be a natural or an artificial bone graft4732, 4832 including a plurality of pores 4790, 4890 forming reservoir4738, 4838 and channels 4740, 4840, porous device 4732, 4832 receivingbone and/or soft tissue ingrowth 4756, 4856 therein. Porous device canbe a natural bone graft 4432 which is configured for being implanted ina bone 4435 and for delivering at least one therapeutic agent 4436directly within a joint capsule 4439 and/or to bone 4435.

The implant according to the present invention may include only oneinternal reservoir. The method can further include refilling reservoir3038 with at least one therapeutic agent 3036 after implant 3032 hasbeen implanted in corporeal body 3034. The method can further includedelivering a plurality of therapeutic agents 3036 to corporeal body 3034via reservoir 3038 and channels 3040. Reservoir 3038 receives at leastone therapeutic agent 3036 after implant 3032 has been implanted incorporeal body 3034 and then communicates at least one therapeutic agent3036 via channels 3040 to treatment site 3042.

The present invention further provides a method of using an orthopaedicimplant, the method including the steps of: providing an orthopaedicimplant body 5044 defining at least one pathway 5040 (shown by arrow5040); receiving at least one therapeutic agent 5036 by implant body5044; implanting the orthopaedic implant 5032 at a selected locationwithin a corporeal body 5034; conveying at least one therapeutic agent5036 from implant body 5044 to a treatment site 5042 relative tocorporeal body 5034 via at least one pathway 5044 using pressuregenerated by corporeal body 5034 to mechanically force at least onetherapeutic agent 5036 from implant body 5044 to treatment site 5042.Structural features in FIGS. 50-51 corresponding to similar features inprior figures have reference characters raised by multiples of 100.Implant body 5044 can be an elastic bladder. Alternatively, the implantimplanted as shown in FIG. 50 can be a spongy element 5132 including aplurality of pores 5190, the at least one pathway 5140 formed by atleast one pore 5190. FIG. 50 shows an orthopaedic implant 5032 accordingto the present invention formed as a bladder or reservoir. Implant 5032thus forms an internal reservoir 5038. Reservoir 5032 has holes orchannels 5040 for delivering the therapeutic agent 5036 to the treatmentsite 5042. FIG. 51 shows a spongy element 5132 includes an implant body5144 with interconnected pores 5190 forming at least one channel 5140.Depending upon the outcome desired, the material of the spongy orsponge-like element 5132 can be a number of possibilities. For example,if the sponge 5132 is to remain implanted for a long time, then aPolyvinyl Alcohol (PVA) or Ivalon sponge, for example, can be used. Onthe other hand, if the sponge 5132 is to last a shorter amount of time,then a collagen based material (i.e., Instat, by Johnson and Johnson,for example) or a gelatin sponge (i.e., Gelfoam, by Pfizer, forexample), for example, can be used. These examples of the sponge 5132are provided by way of example, and not by way of limitation. FIG. 50shows implant 5032 implanted under the quadriceps tendon 5059, as wellas femur 5035, tibia 5037, and patella 5061. The forces experiencedduring walking and other motion can be used to force the therapeuticagent(s) 5036 from the implant 5032. Upon filling reservoir 5038, 5138with the therapeutic agent (either initially and/or as a refill, beforeor after implantation), the therapeutic agent can move from thereservoir 5038, 5138 to the treatment site via channels 5040, 5140.

The present invention further provides a method of using an orthopaedicimplant 5232, the method including the steps of: providing anorthopaedic implant 5232 defining a reservoir 5238 and a plurality ofchannels 5240; implanting implant 5232 at a selected location within acorporeal body 5234, the implant 5232 being implanted into soft tissue5263 of corporeal body 5234; receiving at least one therapeutic agent5236 in reservoir 5238; conveying at least one therapeutic agent 5236from reservoir 5238 to a treatment site 5242 relative to corporeal body5234 via plurality of channels 5240; and delivering at least onetherapeutic agent 5236 to corporeal body 5234. Such an implant 5232 canbe a reservoir, a bladder, a balloon, a sponge, a cloth, or any otherorthopaedic implant configured for being implanted into soft tissue5263. Soft tissue 5263 refers to bodily tissue other than bone. Implant5232 is implanted into soft tissue 5263 such as a muscle, a ligament, atendon, a joint capsule, a fibrous tissue, fat, a membrane, and/orcartilage of said corporeal body. Orthpaedic implant 5232 according tothe present invention and soft tissue 5263 are shown schematically inFIG. 52. Structural features in FIG. 52 corresponding to similarfeatures in prior figures have reference characters raised by multiplesof 100. Upon filling reservoir 5238 with the therapeutic agent (eitherinitially and/or as a refill, before or after implantation), thetherapeutic agent can move from the reservoir 5238 to the treatment sitevia channels 5240.

The present invention thus provides a drug delivery implant configuredfor delivering therapeutic agents for the treatment of osteoarthritis orother diseases. The implant can deliver one or more therapeutic agentsto the targeted joint capsule. Such an implant can be applied to anyjoint. Such joints include, but are not necessarily limited to, hip,knee, ankle, wrist, facets, and joints within the hand and foot.

The implants according to the present invention are placed in or nearthe targeted joint space to allow for the delivery of therapeutic agentsto the joint space. Generally, the implant is designed to hold fast tothe bone and/or soft tissue near the target joint, provide a reservoirto hold therapeutic agents that will be delivered to the region over aperiod of days, weeks, or months, and deliver those agents at a desiredrate. In addition, these devices can allow the implant to be filled atthe time of surgery and/or at any time after surgery and allow thesurgeon to select one or more therapeutic agents to be delivered at anyof these times.

The general shape of the implant according to the present invention canbe that of a screw (see FIG. 30), reservoir, bladder, balloon, plug,anchor, sponge and/or cloth. Implants can be combinations of thesepossibilities, such as a screw with a balloon attached to the screw head(see FIGS. 32 and 33) or a screw or anchor attached to a porous balloonvia a catheter (see FIG. 34).

The implants according to the present invention can be placed directlyin the joint space, in the bone surrounding the joint (see FIGS. 31, 32,33, 34, 44, 45, 46), in the soft tissue surrounding the joint (see FIGS.51-52), or in combinations of these (see FIG. 34).

The goal is to deliver therapeutic agents to the joint space. This canbe accomplished by delivering the agents directly to the joint space, tothe bone and/or soft tissue surrounding the joint, or to a combinationof these. (See FIGS. 31-34, 44-46, 50, 52).

Transport of the therapeutic agents to the tissue can be achieved by,for example, osmosis, diffusion, or pressure. An example of a devicewhich uses osmosis is a rigid reservoir with a permeable membrane toallow for the controlled release of the therapeutic agent. An example ofa device which uses diffusion is a rigid reservoir with deliverychannels (see FIG. 30). An example of a device which uses pressure is anelastic bladder which is filled with therapeutic agents beyond itselastic yield point and which has holes in the bladder. The force of thebladder contracting will force the therapeutic agent through the holesinto the tissue (see FIG. 32). Another example of a device which usespressure to deliver therapeutic agents is one that utilizes the forcesgenerated within a joint and the surrounding tissue to force thetherapeutic agent from the bladder into the surrounding tissue. Forexample, a bladder with delivery pores can be implanted between thequadriceps tendon and the femur (see FIG. 50, and optionally FIG. 34).

Each of the implants according to the present invention (including thosedescribed above) is configured for delivering a plurality of therapeuticagents to the corporeal body via the respective reservoir and channels.Further, with respect to each of the implants (including those describedabove) according to the present invention, the respective reservoir(s)is configured for receiving at least one therapeutic agent after theimplant has been implanted in the corporeal body and then communicatingat least one therapeutic agent via the respective plurality of channelsto the treatment site. Further, with respect to each of the implantsaccording to the present invention (including those described above),the respective reservoir(s) is configured for being refilled with atleast one therapeutic agent after the implant has been implanted in thecorporeal body (see, for example, FIGS. 40-43). Thus, each of theimplants according to the present invention (including those describedabove) can be filled with the therapeutic agent, such as a liquid,before or after implantation and can be refilled after implantation in asimple manner using for instance a pump and a catheter, as describedabove.

While this invention has been described with respect to at least oneembodiment, the present invention can be further modified within thespirit and scope of this disclosure. This application is thereforeintended to cover any variations, uses, or adaptations of the inventionusing its general principles. Further, this application is intended tocover such departures from the present disclosure as come within knownor customary practice in the art to which this invention pertains andwhich fall within the limits of the appended claims.

What is claimed is:
 1. An orthopaedic implant, comprising: an internalfixation device, said internal fixation device including: an exteriorsurface; a threaded section including a reservoir and at least onethreaded section channel fluidly communicating said reservoir with saidexterior surface of said internal fixation device; a head including ahead channel fluidly communicating with said reservoir, a channeldiameter of said head channel being respectively larger than a largestinterior diameter of each threaded section channel, said channeldiameter of said head channel being the same as a large interiordiameter of said reservoir; and a tapered region between and fluidlycommunicating said head channel and said reservoir, said tapered regiondefining a tapered diameter which is less than said channel diameter ofsaid head channel.
 2. The orthopaedic implant according to claim 1,wherein said reservoir is at least partially filled with at least onetherapeutic agent and said at least one threaded section channelcommunicates said reservoir with said exterior surface of said internalfixation device and thereby conveys said at least one therapeutic agentfrom said reservoir to said exterior surface of said internal fixationdevice.
 3. The orthopaedic implant according to claim 1, wherein saidinternal fixation device includes only one said reservoir.
 4. Theorthopaedic implant according to claim 1, wherein said reservoir isrefillable.
 5. The orthopaedic implant according to claim 1, whereinsaid internal fixation device comprises at least one ofpolyetheretherketone (PEEK), polyetherketone (PEK), polyaryletherketone(PAEK), polyethylene, polylactic acid (PLA), and polyglycolic acid(PGA).
 6. The orthopaedic implant according to claim 1, wherein saidthreaded section includes at least one thread comprising at least one ofa polymer, a reinforced polymer, and a metal.
 7. The orthopaedic implantaccording to claim 1, further comprising a second reservoir in fluidcommunication with said reservoir.
 8. The orthopaedic implant accordingto claim 7, wherein said second reservoir is in fluid communication withsaid reservoir via said head channel.
 9. The orthopaedic implantaccording to claim 7, wherein said reservoir is at least partiallyfilled with a first therapeutic agent and said second reservoir is atleast partially filled with at least one of said first therapeutic agentand a second therapeutic agent different from said first therapeuticagent.
 10. The orthopaedic implant according to claim 1, wherein saidinternal fixation device includes a plurality of threaded sectionchannels including at least one threaded section channel on a first sideof said reservoir and at least one threaded section channel on a secondside of said reservoir opposite said first side.
 11. The orthopaedicimplant according to claim 1, wherein each threaded section channel hasan interior diameter and a length which is greater than said interiordiameter.
 12. An orthopaedic implant, comprising: an internal fixationdevice, said internal fixation device including: an exterior surface; athreaded section including a reservoir and at least one threaded sectionchannel fluidly communicating said reservoir with said exterior surfaceof said internal fixation device; a head including a head channelfluidly communicating with said reservoir, a channel diameter of saidhead channel being respectively larger than a largest interior diameterof each threaded section channel; and a tapered region between andfluidly communicating said head channel and said reservoir, said taperedregion defining a tapered diameter which is less than said channeldiameter of said head channel, said tapered region defining a minimumdiameter adjacent said head channel and a maximum diameter adjacent saidreservoir.
 13. The orthopaedic implant according to claim 12, whereinsaid reservoir is at least partially filled with at least onetherapeutic agent and said at least one threaded section channelcommunicates said reservoir with said exterior surface of said internalfixation device and thereby conveys said at least one therapeutic agentfrom said reservoir to said exterior surface of said internal fixationdevice.
 14. The orthopaedic implant according to claim 12, wherein saidinternal fixation device includes only one said reservoir.
 15. Theorthopaedic implant according to claim 12, wherein said threaded sectionincludes at least one thread comprising at least one of a polymer, areinforced polymer, and a metal.
 16. The orthopaedic implant accordingto claim 12, further comprising a second reservoir in fluidcommunication with said reservoir.
 17. The orthopaedic implant accordingto claim 16, wherein said second reservoir is in fluid communicationwith said reservoir via said head channel.
 18. The orthopaedic implantaccording to claim 16, wherein said reservoir is at least partiallyfilled with a first therapeutic agent and said second reservoir is atleast partially filled with at least one of said first therapeutic agentand a second therapeutic agent different from said first therapeuticagent.
 19. The orthopaedic implant according to claim 12, wherein saidinternal fixation device includes a plurality of threaded sectionchannels including at least one threaded section channel on a first sideof said reservoir and at least one threaded section channel on a secondside of said reservoir opposite said first side.
 20. The orthopaedicimplant according to claim 12, wherein said channel diameter of saidhead channel is the same as a large interior diameter of said reservoir.